This checklist provides documentation requirements for various categories of applications pertaining to new drugs, global clinical trials, and bioequivalence studies for export purposes. It includes requirements for applications of investigational new drugs, new drugs to be introduced in the country, global clinical trials, clinical trial protocols, clinical study reports, and applications for approval of modified dosage forms or new indications of approved drugs. Documentation such as the clinical trial protocol, informed consent documents, pre-clinical safety data, and approval from an ethics committee are required.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
The document outlines regulatory guidelines for validating traditional medicines through preclinical and clinical studies. It discusses the types of information required in investigational new drug applications (INDs) for botanical drug products, including descriptions of the botanical ingredients, manufacturing and quality controls, pharmacology, toxicity studies, and previous human experience. The level of information required increases from initial clinical trials to expanded clinical trials and approaches for new drug applications (NDAs). Preclinical studies help identify compounds likely to be safe and effective in humans, while clinical trials progress from small initial safety studies to larger efficacy trials.
The Central Drug Standard Control Organisation (CDSCO) is India's main drug regulatory body. It regulates pharmaceuticals, medical devices, and clinical trials. CDSCO functions under the Ministry of Health and Family Welfare. It oversees drug approval processes, clinical trial approval, import/export of drugs, medical devices regulation, and operates an online licensing portal called SUGAM. CDSCO's head office is in New Delhi and it has various zonal, sub-zonal, and port offices that perform regulatory functions like GMP audits and sample testing.
The document summarizes the WHO Prequalification Programme, which aims to ensure that medicines and health products meet global standards of quality, safety and efficacy. The key points are:
1. The programme comprehensively evaluates products based on manufacturer submissions and site inspections to verify compliance with WHO standards. Products that meet standards are added to the WHO prequalified lists.
2. The programme was launched in 2001 to address quality issues with medicines for HIV/AIDS, malaria, and tuberculosis in developing countries. It has since expanded to other health products and diseases.
3. The prequalification process involves an expression of interest, dossier submission and evaluation, site inspections, listing of prequalified products, ongoing monitoring, and de
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
The document outlines regulatory guidelines for validating traditional medicines through preclinical and clinical studies. It discusses the types of information required in investigational new drug applications (INDs) for botanical drug products, including descriptions of the botanical ingredients, manufacturing and quality controls, pharmacology, toxicity studies, and previous human experience. The level of information required increases from initial clinical trials to expanded clinical trials and approaches for new drug applications (NDAs). Preclinical studies help identify compounds likely to be safe and effective in humans, while clinical trials progress from small initial safety studies to larger efficacy trials.
The Central Drug Standard Control Organisation (CDSCO) is India's main drug regulatory body. It regulates pharmaceuticals, medical devices, and clinical trials. CDSCO functions under the Ministry of Health and Family Welfare. It oversees drug approval processes, clinical trial approval, import/export of drugs, medical devices regulation, and operates an online licensing portal called SUGAM. CDSCO's head office is in New Delhi and it has various zonal, sub-zonal, and port offices that perform regulatory functions like GMP audits and sample testing.
The document summarizes the WHO Prequalification Programme, which aims to ensure that medicines and health products meet global standards of quality, safety and efficacy. The key points are:
1. The programme comprehensively evaluates products based on manufacturer submissions and site inspections to verify compliance with WHO standards. Products that meet standards are added to the WHO prequalified lists.
2. The programme was launched in 2001 to address quality issues with medicines for HIV/AIDS, malaria, and tuberculosis in developing countries. It has since expanded to other health products and diseases.
3. The prequalification process involves an expression of interest, dossier submission and evaluation, site inspections, listing of prequalified products, ongoing monitoring, and de
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
FOMAT Medical Research is a site research network specializes in developing clinical. We offer a wide range of solutions for Sponsors, Clinical Contract Organizations (CROs), and Sites throughout the Americas. Visit here- https://www.fomatmedical.com
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. It was formed in 2003 by merging the Medicines Control Agency and Medical Devices Agency. The MHRA licenses pharmaceutical companies, importers, clinical trials and new medicines. It oversees the drug development process from discovery through clinical trials to licensing. The MHRA also monitors drug safety after approval and can renew, cancel or amend licenses as needed.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Bioavailability and bioequivalance studies and Regulatory aspectsRumel Dey
This document discusses bioavailability and bioequivalence studies, including definitions, protocols, and regulatory requirements. It defines key terms like bioavailability, bioequivalence, pharmaceutical equivalents, and therapeutic equivalents. It describes the reference and test products used in studies and compares NDA and ANDA review processes. It provides details on the design, conduct, and statistical evaluation of bioavailability and bioequivalence studies. It also discusses biowaiver options and the use of pharmacodynamic and dissolution studies.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
The document outlines the regulatory requirements and guidelines in India for permission to import, manufacture, and conduct clinical trials of new drugs. It discusses the relevant sections of Schedule Y and the Drugs and Cosmetics Rules, 1945. Key points include the application process for import/manufacture using Form 44, responsibilities of sponsors and investigators, ethics committee oversight, and guidelines for the different phases of clinical trials from Phase I to Phase IV. It also addresses requirements for special populations like pediatrics, geriatrics, and pregnant/nursing women. Post-marketing surveillance and periodic safety update reporting are mandated.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
The European Medicines Agency (EMA) regulates medicines for human and veterinary use in Europe. Based in London, the EMA ensures medicines are safe and effective, working with authorities in EU member states. Over its 25 year history, the EMA has authorized over 1000 human and 200 veterinary medicines. While facilitating timely access to medicines, the EMA monitors safety and provides information to healthcare professionals and patients, but does not regulate pricing, advertising, patents, or certain other products. The EMA comprises several scientific committees and is supported by the European Directorate for Quality of Medicines.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
MedDRA is a standardized medical terminology used in the pharmaceutical industry and regulatory bodies for coding adverse event reports. It contains over 60,000 terms organized into a hierarchical structure with 5 levels across 26 system organ classes. MedDRA allows for improved data entry of reports and flexible retrieval of information due to its multiaxial structure and guidance documents provide recommendations for its effective use and analysis.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
Institutional review board by akshdeep sharmaAkshdeep Sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
The document discusses clinical trials and good clinical practice (GCP) guidelines. It provides definitions and explanations of key concepts.
Specifically, it defines a clinical trial as an investigation in human subjects to discover or verify the effects of an investigational product. It describes GCP as international standards for clinical trial conduct that ensure data credibility and protect subject rights. The guidelines aim to harmonize standards across regions through organizations like the International Council for Harmonization.
The document then outlines investigator responsibilities in areas like trial preparation, conduct, and closure to ensure compliance with GCP standards and protect subject safety and data integrity.
1) The document outlines guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India.
2) It discusses requirements for various types of applications and studies required including animal pharmacology/toxicology, clinical trial phases, special populations, and post-marketing surveillance.
3) The guidelines specify responsibilities of sponsors, investigators, and ethics committees in clinical trials and informed consent requirements.
This document provides guidelines for conducting clinical trials and importing or manufacturing new drugs for sale according to Schedule Y of the Drugs and Cosmetics Act of 1940 in India. It outlines the application process and required data to be submitted, including chemical/pharmaceutical information, pre-clinical toxicology and pharmacology studies in animals, protocols for human clinical trials through various phases, and post-marketing surveillance requirements. Ethics committee approval and informed consent of participants are necessary. Manufacturers must establish the drug's quality, safety, and efficacy primarily through clinical trials conducted in India.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
FOMAT Medical Research is a site research network specializes in developing clinical. We offer a wide range of solutions for Sponsors, Clinical Contract Organizations (CROs), and Sites throughout the Americas. Visit here- https://www.fomatmedical.com
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. It was formed in 2003 by merging the Medicines Control Agency and Medical Devices Agency. The MHRA licenses pharmaceutical companies, importers, clinical trials and new medicines. It oversees the drug development process from discovery through clinical trials to licensing. The MHRA also monitors drug safety after approval and can renew, cancel or amend licenses as needed.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Bioavailability and bioequivalance studies and Regulatory aspectsRumel Dey
This document discusses bioavailability and bioequivalence studies, including definitions, protocols, and regulatory requirements. It defines key terms like bioavailability, bioequivalence, pharmaceutical equivalents, and therapeutic equivalents. It describes the reference and test products used in studies and compares NDA and ANDA review processes. It provides details on the design, conduct, and statistical evaluation of bioavailability and bioequivalence studies. It also discusses biowaiver options and the use of pharmacodynamic and dissolution studies.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The document discusses the role of patients, healthcare professionals, and academics in the European Medicines Agency's (EMA) process of approving medicines in the European Union. It describes how patients and patient organizations can provide input and expertise at various stages of the medicine development and review process. This includes involvement in scientific committees, evaluation of product information for patients, and review of safety communications. While patient participation has increased in recent years, challenges remain around representation, measuring impact, and ensuring comprehensive training. The EMA also facilitates collaboration with healthcare professionals and academics to enhance regulation and research.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
The document outlines the regulatory requirements and guidelines in India for permission to import, manufacture, and conduct clinical trials of new drugs. It discusses the relevant sections of Schedule Y and the Drugs and Cosmetics Rules, 1945. Key points include the application process for import/manufacture using Form 44, responsibilities of sponsors and investigators, ethics committee oversight, and guidelines for the different phases of clinical trials from Phase I to Phase IV. It also addresses requirements for special populations like pediatrics, geriatrics, and pregnant/nursing women. Post-marketing surveillance and periodic safety update reporting are mandated.
21CFR 320- BIO AVAILABILITY AND BIO EQUIVALENCE REQUIREMENTSPallavi Christeen
this presentation describes briefly about Bioavailability and Bioequivalence requirements as per US FDA Code of Federal Regulations under title 21 and chapter 320
The European Medicines Agency (EMA) regulates medicines for human and veterinary use in Europe. Based in London, the EMA ensures medicines are safe and effective, working with authorities in EU member states. Over its 25 year history, the EMA has authorized over 1000 human and 200 veterinary medicines. While facilitating timely access to medicines, the EMA monitors safety and provides information to healthcare professionals and patients, but does not regulate pricing, advertising, patents, or certain other products. The EMA comprises several scientific committees and is supported by the European Directorate for Quality of Medicines.
regulatory approval process of drug, cosmetic and herbals in canada Richa Patel
The document discusses the regulatory approval process for drugs, cosmetics, nutraceuticals, and herbal products in Canada. It provides details on:
1) How drugs are reviewed and authorized for sale once they have undergone assessment by Health Canada for safety, efficacy, and quality.
2) The roles and responsibilities of the Health Products and Food Branch in regulating therapeutic and diagnostic products in Canada.
3) The definitions of key terms like drugs, cosmetics, natural health products, and personal care products according to Canadian regulations.
MedDRA is a standardized medical terminology used in the pharmaceutical industry and regulatory bodies for coding adverse event reports. It contains over 60,000 terms organized into a hierarchical structure with 5 levels across 26 system organ classes. MedDRA allows for improved data entry of reports and flexible retrieval of information due to its multiaxial structure and guidance documents provide recommendations for its effective use and analysis.
This document summarizes the regulations and history around generic drug applications (ANDAs) in the United States. It explains that an ANDA is an application to produce a generic version of an approved drug that is the same in dosage, strength, and use. The document outlines the basic requirements for generic drugs and discusses the historical approval pathways including ANDAs, paper NDAs, and monographs that preceded the modern system established by the Hatch-Waxman Act of 1984. This law standardized the ANDA process and established provisions to balance generic competition with patent protections for brand drugs.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
This document outlines the key components and considerations for developing a clinical trial protocol. It discusses that a protocol is a complete written plan for a research study involving human subjects. It identifies important sections such as the title page, objectives, study design, safety reporting, statistical analysis, and informed consent. It emphasizes that the protocol language should be clear, concise, and understandable for diverse readers. It also provides guidance on properly writing eligibility criteria, adverse event definitions, and obtaining informed consent to protect human subjects.
Institutional review board by akshdeep sharmaAkshdeep Sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
The document discusses clinical trials and good clinical practice (GCP) guidelines. It provides definitions and explanations of key concepts.
Specifically, it defines a clinical trial as an investigation in human subjects to discover or verify the effects of an investigational product. It describes GCP as international standards for clinical trial conduct that ensure data credibility and protect subject rights. The guidelines aim to harmonize standards across regions through organizations like the International Council for Harmonization.
The document then outlines investigator responsibilities in areas like trial preparation, conduct, and closure to ensure compliance with GCP standards and protect subject safety and data integrity.
1) The document outlines guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India.
2) It discusses requirements for various types of applications and studies required including animal pharmacology/toxicology, clinical trial phases, special populations, and post-marketing surveillance.
3) The guidelines specify responsibilities of sponsors, investigators, and ethics committees in clinical trials and informed consent requirements.
This document provides guidelines for conducting clinical trials and importing or manufacturing new drugs for sale according to Schedule Y of the Drugs and Cosmetics Act of 1940 in India. It outlines the application process and required data to be submitted, including chemical/pharmaceutical information, pre-clinical toxicology and pharmacology studies in animals, protocols for human clinical trials through various phases, and post-marketing surveillance requirements. Ethics committee approval and informed consent of participants are necessary. Manufacturers must establish the drug's quality, safety, and efficacy primarily through clinical trials conducted in India.
This document provides an overview of Schedule Y, which establishes requirements and guidelines for conducting clinical trials and obtaining permission to import or manufacture new drugs in India. Schedule Y aims to frame guidelines for clinical research in line with global standards. It outlines application procedures, ethics committee requirements, pre-clinical and clinical data to be submitted, protocol elements, and other rules to ensure safety and efficacy of investigational products. The objectives of Schedule Y are to regulate clinical trials and new drugs in India according to current scenarios and integrate the country into global drug development while improving clinical trial quality.
The document outlines appendices related to data requirements for conducting clinical trials of new drugs in India. Appendix I provides details on various types of data that must be submitted, including chemical/pharmaceutical information, animal pharmacology/toxicology studies, human clinical trial phases, regulatory information from other countries, and prescribing information. It also describes stability testing and validation requirements. Appendix II discusses the structure and contents of clinical study reports. Appendix III covers principles of animal toxicology studies.
The document provides guidelines on the data required to be submitted for conducting clinical trials or importing/manufacturing new drugs in India. It includes details on chemical/pharmaceutical information, animal pharmacology/toxicology studies, human clinical trial phases, special studies like bioavailability/bioequivalence studies, regulatory status in other countries, prescribing information, and samples/testing protocols. Appendices provide more details on topics like clinical study report format/structure, animal toxicology parameters, and male fertility studies.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
PART 1 _ Documentation of drug trials and regulatory filings (1).pptxDilsarGohil1
The document discusses documentation required for Investigational New Drug (IND) applications submitted to regulatory authorities like the FDA. An IND application is required to get approval to start clinical trials of an investigational drug. It must include preclinical animal study and toxicity data, manufacturing information, clinical trial protocols, and prior human research data. If approved, the IND allows the sponsor to begin clinical trials to investigate safety and efficacy of the new drug in humans. The clinical trials are divided into four phases with increasing number of participants.
Regulatory affairs and Intellectual Property Rightssantoshnarla
The document provides details about Dr. Santosh Kumar Narla's academic and professional background. It states that he holds a Ph.D. in Pharmaceutical Sciences and has over 15 years of experience in formulation development and regulatory affairs. He currently works as a manager of regulatory affairs at Dr. Reddy's Laboratories in Hyderabad. It also lists his publications and presentations at national and international conferences.
Worldwide comprehensive study of guideline on clinical trialRGPV BHOPAL
The document provides information on various aspects of clinical trials including:
- The different phases of clinical trials from Phase 0 to Phase V
- Key elements of a clinical trial protocol such as objectives, design, and methodology
- Regulatory requirements for conducting clinical trials including compliance with ICH GCP guidelines
- Common recruitment strategies and important documents required for clinical trial authorization applications such as the clinical trial protocol, investigator brochure, and informed consent forms.
This document discusses Investigational New Drug Applications (INDs), which are required for clinical studies involving investigational drugs. There are three main types of INDs: investigator INDs submitted by physicians, emergency use INDs for emergency situations, and treatment INDs for drugs showing promise for serious conditions. The FDA reviews INDs to ensure proposed clinical trials will not expose subjects to unnecessary risks, investigators are qualified, and informed consent and institutional review board oversight are in place. IND applications must provide preclinical and manufacturing data as well as detailed protocols for proposed clinical studies. The FDA's objectives in reviewing INDs are to ensure safety, rights of subjects, and adequate scientific evaluation of a drug's effectiveness.
This document provides guidelines for conducting clinical trials and obtaining regulatory approval for new drugs in India. It outlines the requirements and process for importing or manufacturing new drugs, including application forms, fees, pre-clinical and clinical data requirements, and responsibilities of sponsors, investigators and ethics committees. Key points covered include Schedule Y which provides Good Clinical Practice guidelines; types of clinical trials and special population studies; and the roles of regulatory authorities like the Drug Controller General of India.
this slide share will provide information about drug discovery and development.in this, how the drug is discovered and what type of procedures and instructions followed during discovery and development of a new drug and also give limitations of drug discovery and development process.
The document outlines the regulatory requirements and guidelines in India for conducting clinical trials and obtaining permission to import or manufacture new drugs. It discusses the various schedules under the Drugs and Cosmetics Act that apply. It provides details on the application process, responsibilities of sponsors, investigators and ethics committees. It also describes the different phases of clinical trials including objectives and key requirements for human pharmacology studies, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing trials.
The document summarizes Schedule Y of the Drugs and Cosmetics Act, which covers requirements for permission to import or manufacture new drugs in India and conduct clinical trials. It discusses rules for applications, responsibilities of sponsors, investigators and ethics committees. It also outlines the regulatory authorities involved and fees for applications. Requirements include preclinical and clinical data to be submitted along with applications for marketing approval or conducting trials.
Schedule Y outlines the requirements and guidelines for permission to import and manufacture new drugs in India and to conduct clinical trials. It aims to regulate clinical research and new drugs. Permission is required from the Central Drugs Standard Control Organization and Drugs Technical Advisory Board for importing or manufacturing new drugs as well as conducting clinical trials. Applications must include chemical, pharmaceutical, pre-clinical, and clinical data. Clinical trials must be approved by licensing authorities and ethics committees and informed consent is required. Sponsors and investigators have responsibilities to patients' rights and safety. Trials progress through Phases I-IV and special studies on populations like geriatrics are addressed along with post-marketing surveillance. Detailed appendices provide guidelines on submitting applications and
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
The document discusses the process of drug development from discovery through clinical trials and regulatory approval. It covers the various phases including: drug discovery to identify candidate molecules; preclinical testing in animals to assess safety; clinical trials in three phases with Phase I examining safety in healthy volunteers, Phase II evaluating efficacy in patients, and Phase III large-scale trials to further assess safety and efficacy to support regulatory approval. Informed consent is required from participants and protocols must comply with good clinical practice guidelines.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval for human clinical trials of an experimental drug. An IND application includes preclinical animal data, manufacturing information, and clinical trial protocols. It allows 30 days for FDA review to ensure the trials will not expose subjects to unreasonable risks. The FDA reviews INDs from medical, chemistry, pharmacology and statistical perspectives and can notify the sponsor of deficiencies. Clinical trials can then proceed unless a clinical hold is issued.
The document discusses the purpose and requirements of an Investigational New Drug (IND) application submitted to the FDA. An IND allows a company to ship an experimental drug and conduct clinical trials in humans. It provides safety data and details of planned trials for FDA review to ensure risks are minimized for subjects. A complete IND includes chemistry, manufacturing, pharmacology, protocols and other application materials for FDA evaluation before trials may begin.
Similar to DCGI prescreening new drug applications (20)
Here are some tips for calculating personnel costs in a project budget:
- Project participants' time: Calculate hourly or daily rates based on annual salary divided by total working days per year. Include time for meetings, preparation, travel, etc.
- Support staff time: Include any administrative assistance, technical support, etc. Calculate rates the same way.
- Consultants/experts: Include fees if bringing in outside expertise. Get quotes in advance.
- Overhead/indirect costs: Factor in a percentage (e.g. 10-20%) of direct personnel costs to cover office space, utilities, equipment use, etc.
- Fringe benefits: Include costs for health insurance, retirement contributions, etc.
This document provides guidelines for conducting and reporting health research. It covers topics such as identifying a health problem, writing a research proposal, research ethics, developing research instruments, types of study designs, sampling methods, descriptive and inferential statistics, and data processing. The document contains an outline with 4 sections and over 70 subtopics to guide researchers through the entire research process from start to finish.
Phase I clinical trials play a critical role in translating new cancer therapies from basic research findings into clinical applications. They represent the first step in testing new agents in patients. While the primary goal is to determine the maximum tolerated dose, phase I trials may provide therapeutic benefit to some patients. They have led to the development of many currently approved and widely used cancer drugs. However, phase I trials are often misunderstood and subject to misconceptions regarding their goals, conduct, and value in cancer research and treatment.
This document discusses the importance of effective trial management for clinical trials. It notes that many trials fail due to a lack of structured management approaches. The key elements of effective trial management include:
1) Developing a robust project management plan that outlines the trial processes and responsibilities.
2) Establishing an efficient trial management team with clear roles.
3) Carefully planning recruitment strategies and ensuring minimal workload for investigators and participants.
4) Implementing standardized, transparent systems for data management and quality control.
Effective trial management requires considering clinical trials from a business management perspective and applying project management principles.
Clinical trial inspection programme of indiaitsaruns
This document provides guidance on conducting clinical trial inspections. It outlines objectives to verify GCP compliance, credibility of data, and compliance with regulations. It describes planning inspections, including study selection, preparation, and scheduling. Procedures for inspecting clinical trial sites and sponsor/CRO facilities are covered, examining documentation, organization, product accountability, and ethics compliance. The goal is to safeguard participants and ensure integrity and oversight of clinical research.
1. Checklist for applications for grant of approval
of various categories of New Drug, Global
Clinical trial and Bioequivalence study for
export purpose.
2. INDEX
S.No Categories
1 Applications for Investigational New Drugs
2 Applications for Approval of New Drugs going to be introduced for the first
time in the country
3 Applications for Global Clinical Trial
4 Protocol amendment for Global Clinical Trial
5 Test Licence for Global Clinical Trial
6 Site addition / deletion for Global Clinical Trial
7 Applications for approval of New Drug formulation already approved in the
country
8 Applications for approval of Bulk Drug (New Drug) already approved in the
country
9 Applications for approval of New Indication
10 Applications for approval of New Dosage Form / New Route of administration
of drug
11 Applications for approval of Modified Release Dosage Form
12 Applications for BE NOC for export purpose
3. 1. APPLICATIONS FOR INVESTIGATIONAL NEW DRUGS (INDs)
# Documents required to be submitted Status
Yes No
1 Application for (permission for manufacture /import/clinical trial –
purpose should be clearly mentioned)
2 Name of the applicant
3 Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
4 Application in Form 44 complete in all respect duly signed and stamped
by authorized person of the firm
5 Treasury Challan of INR 50,000 (for Phase I) or INR 25,000 (for
Phase II / III)
8 Copy of valid manufacturing license in Form 25/28 along with copy of
form 29
9 Source of bulk drugs.
10. Information on active ingredients
a) Physiochemical data (Chemical name and Structure, Physical properties etc.)
b) Analytical data (elemental analysis, NMR spectrum, IR Spectrum, UV spectrum
etc.)
c) Complete monograph specification including identification, identity/quantification of
impurities, enantiomeric purity, assay etc.)
d) Certificate of analysis
e) Validation [assay method, impurity estimation method, residual solvent/other
volatile impurities(OVI) estimation method]
f) Reference standard characterization,
g) Material safety data sheet.
11 Data on Formulation:
a) Details on Dosage Form
b) Master manufacturing formula
c) Details of the formulation (including inactive ingredients)
d) Finished product specification
e) In process quality control check
f) Excipient compatibility study
g) Validation of analytical method
4. h) Certificate of analysis including identification, pH, content uniformity,
impurities, assay etc.
i) Dissolution data in case of oral dosage forms as appropriate
j) Stability study evaluation as per requirements of schedule Y
12 Animal Pharmacology including summary of the study, general
pharmacological actions, specific pharmacological actions, follow-up
and supplemental safety Pharmacology Studies, Pharmacokinetics
including absorption, distribution; metabolism; excretion
13 Animal toxicology data as per Schedule Y.
a. systemic toxicity studies,
i. single dose toxicity
ii. repeated dose toxicity
b. Male Fertility Study
c. Female Reproduction and Developmental Toxicity Studies (for all
drugs proposed to be studied or used in women of child bearing
age)
d. Local toxicity
i. Dermal toxicity
(for products meant for topical (dermal) application)
ii. Ocular toxicity
(for products meant for ocular instillation)
iii. Inhalation toxicity
(conducted with the formulation proposed to be used via
inhalation route)
iv. Vaginal toxicity
(for products meant for topical application to vaginal mucosa)
v. Photoallergy or dermal phototoxicity
(required if the drug or a metabolite is related to an agent
causing photosensitivity or the nature of action suggests such a
potential)
vi. Rectal tolerance test
(For all preparations meant for rectal administration)
e. Genotoxicity
f. Allergenicity/Hypersensitivity
g. Carcinogenicity
(Carcinogenicity studies should be performed for all drugs that are
expected to be clinically used for more than 6 months as well as
for drugs used frequently in an intermittent manner in the
treatment of chronic or recurrent conditions. However, completed
rodent carcinogenicity studies are not needed in advance of the
conduct of large scale clinical trials, unless there is a special
concern for the patient population)
Reports of following toxicity studies should be submitted alongwith
clinical trial applications of different Phases for INDs:
5. For Phase I Clinical Trials
Systemic Toxicity studies
(i) Single dose toxicity studies
(ii) Dose Ranging Studies
(iii) Repeat-dose systemic toxicity studies of appropriate duration to
support the duration of proposed human exposure.
Male fertility study
In-vitro genotoxicity tests
Relevant local toxicity studies with proposed route of clinical application
(duration depending on proposed length of clinical exposure)
Allergenicity/Hypersensitivity tests (when there is a cause for concern or
for parenteral drugs, including dermal application)
Photo-allergy or dermal photo-toxicity test (if the drug or a metabolite is
related to an agent causing photosensitivity or the nature of action
suggests such a potential)
For Phase II Clinical Trials
Provide a summary of all the non-clinical safety data (listed above)
already submitted while obtaining the permissions for Phase I trial, with
appropriate references.
In case of an application for directly starting a Phase II trial - complete
details of the non-clinical safety data needed for obtaining the permission
for Phase I trial, as per the list provided above must be submitted.
Repeat-dose systemic toxicity studies of appropriate duration to support
the duration of proposed human exposure
In-vitro and In-vivo genotoxicity tests.
Segment II reproductive/developmental toxicity study (if female patients
of child bearing age are going to be involved)
For Phase III Clinical Trials
Provide a summary of all the non-clinical safety data (listed above)
already submitted while obtaining the permissions for Phase I and II
trials, with appropriate references.
In case of an application for directly initiating a Phase III trial - complete
details of the non-clinical safety data needed for obtaining the
permissions for Phase I and II trials, as per the list provided above must
be provided.
Repeat-dose systemic toxicity studies of appropriate duration to support
the duration of proposed human exposure
Reproductive/developmental toxicity studies
In-vitro and In-vivo genotoxicity tests.
Segment I (if female patients of child bearing age are going to be
involved), and
Segment III (for drugs to be given to pregnant or nursing mothers or
6. where there are indications of possible adverse effects on foetal
development).
Carcinogenicity studies (when there is a cause for concern or when the
drug is to be used for more than 6 months).
14 Human / Clinical pharmacology (Phase I) including summary of the study
and reports
i. Summary
ii. Specific Pharmacological effects
iii. General Pharmacological effects
iv. Pharmacokinetics, absorption, distribution, metabolism,
v. excretion
vi. Pharmacodynamics / early measurement of drug activity
15 Therapeutic exploratory trials (Phase II) including summary of the study
and reports
16 Therapeutic confirmatory trials (Phase III) including summary of the
study and individual study reports with listing of sites and Investigators.
7. 17. STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL TRIAL PROTOCOL
# Documents required to be submitted Status
Yes No
1. Title Page
2. Table of Contents
3. Study Objective(s) (primary as well as secondary) and their logical
relation to the study design.
4. Study Design
5. Study Population
6. Subject Eligibility - Inclusion Criteria and Exclusion Criteria
7. Study Assessments
8. Study Treatment
9. Adverse Events
10. Ethical Considerations
11. Study Monitoring and Supervision
12. Study Monitoring and Supervision
13. Investigational Product Management
14. Data Analysis
15. Undertaking by the Investigator: This shall include all the details / elements as
mentioned in the Appendix VII of Schedule-Y.
16. Informed consent documents (patient information sheet, informed
consent form etc.) as per Appendix V of Schedule-Y should mention the
following: “In case of study related injury or death M/s. «NAME OF THE
COMPANY» will provide complete medical care along with
compensation for the injury or death”.
8. 18. STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL STUDY REPORTS
# Documents required to be submitted Status
Yes No
1. Title Page
2. Study Synopsis
3. Statement of compliance with the „Guidelines for Clinical Trials on
Pharmaceutical Products in India
4. List of Abbreviations and Definitions
5. Table of contents
6. Copy of Ethics Committee approval
7. Study Team
8. Introduction
9. Study Objective
10. Investigational Plan
11. Trial Subjects
12. Efficacy evaluation
13. Safety Evaluation
14. Discussion and overall Conclusion
15. List of References
Note:
1. All items mentioned above may not be applicable to all drugs. The items not relevant to a
particular new drug should be marked with “Not Applicable (NA)”.
9. 2. In case the application is for clinical trial permission :-
(a) adequate chemical and pharmaceutical information should be provided to ensure the
proper identity, purity, quality & strength of the investigational product, the amount of
information needed may vary with the Phase of clinical trials, proposed duration of trials,
dosage forms and the amount of information otherwise available
(b) In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of all
the new changes incorporated alongwith justification / reasons for the change.
(c) Ethics Committee Approval: Ethical approval should be obtained from Ethics
Committee located in the same area where the clinical trial site is located.
(d) The proposed clinical trial study centers should be geographically distributed in the
country and should also include clinical sites which have their own Institutional Ethics
Committee.
10. 2. CHECKLIST FOR ACCEPTABILITY OF APPLICATION PERTANING TO GRANT OF
PERMISSION TO IMPORT OR MANUFACTURE NEW DRUGS GOING TO BE
INTRODUCED FOR THE FIRST TIME IN THE COUNTRY FOR SALE OR TO
UNDERTAKE CLINICAL TRIALS
# Documents required to be submitted Status
Yes No
1 Application for permission to import or manufacture new drugs for
sale or to undertake clinical trials - Purpose should be clearly
mentioned.
a. Name of the applicant
b. Name of the New Drug
c. Composition of the New Drug
d. Proposed indication
2 Application in Form 44 should be complete in all respect and signed by
the authorized person of the firm with name and designation
3 Treasury Challan of Rs.50,000 and should mention the name of the
New Drug including correct head of the account, payable at, bank
clearance, etc.
4 Copy of valid manufacturing license in Form 25/28 along with copy of
Form 29
5 Source of bulk drugs
a) In-house
b) Other than in-house.
If source is other than in-house, a copy of consent letter from
manufacturer of the bulk drug should be submitted and the manufacture of
the bulk drug should also file application for the bulk drug.
6 Information on active ingredients
a) Physiochemical data (Chemical name and Structure, Physical
properties etc.)
b) Analytical data (elemental analysis, NMR spectrum, IR Spectrum, UV
spectrum etc.)
c) Complete monograph specification including identification, identity /
quantification of impurities, enantiomeric purity, assay etc.)
d) Certificate of analysis
e) Validation [assay method, impurity estimation method, residual
solvent/other volatile impurities(OVI) estimation method]
f) Reference standard characterization,
g) Material safety data sheet.
7 Data on Formulation:
a) Master manufacturing formula
b) Details of the formulation (including inactive ingredients)
c) Finished product specification
d) In process quality control check
11. e) Excipient compatibility study
f) Process validation
g) Validation of analytical method
h) Certificate of analysis including identification, pH, content uniformity,
impurities, assay etc.
i) Dissolution data in case of oral dosage forms as appropriate
j) Stability study evaluation as per requirements of schedule Y
8 Animal Pharmacology including summary of the study, general
pharmacological actions, specific pharmacological actions, follow-up and
supplemental safety Pharmacology Studies, Pharmacokinetics including
absorption, distribution; metabolism; excretion
9 Animal toxicology data as per Schedule Y.
h. Systemic toxicity studies,
i. single dose toxicity
ii. repeated dose toxicity
i. Male Fertility Study
j. Female Reproduction and Developmental Toxicity Studies
(for all drugs proposed to be studied or used in women of child
bearing age)
k. Local toxicity
vii. Dermal toxicity
(for products meant for topical (dermal) application)
viii. Ocular toxicity
(for products meant for ocular instillation)
ix. Inhalation toxicity
(conducted with the formulation proposed to be used via
inhalation route)
x. Vaginal toxicity
(for products meant for topical application to vaginal
mucosa)
xi. Photoallergy or dermal phototoxicity
(required if the drug or a metabolite is related to an agent
causing photosensitivity or the nature of action suggests
such a potential)
xii. Rectal tolerance test
(For all preparations meant for rectal administration)
l. Genotoxicity
m. Allergenicity/Hypersensitivity
n. Carcinogenicity
(Carcinogenicity studies should be performed for all drugs that are
expected to be clinically used for more than 6 months as well as for
drugs used frequently in an intermittent manner in the treatment of
chronic or recurrent conditions. However, completed rodent
carcinogenicity studies are not needed in advance of the conduct of
large scale clinical trials, unless there is a special concern for the
12. patient population)
10 Human / Clinical pharmacology (Phase I) including summary of the
study and reports
11 Therapeutic exploratory trials (Phase II)
12 Therapeutic confirmatory trials (Phase III).
13 Regulatory status in other countries, as appropriate.
a) Names of the countries where the drug is marketed / approved
along with package insert circulated in those countries and since
when it is marketed in those countries. Specific names of countries
where the drug is marketed should also be mentioned in the covering
letter.
b) Names of the countries where the drug is withdrawn, if any, with
reasons ( Information in respect of restrictions imposed, if any, on
the use of the drug in other countries, e.g. dosage limits, exclusion
of certain age groups, warning about adverse drug reactions etc.)
c) In case import of drug, Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), as appropriate.
14 Copy of proposed prescribing information. The prescribing information
(package insert) shall comprise the following sections: generic name;
composition; dosage form/s, indications; dose and method of
administration; use in special populations (such as pregnant women,
lactating women, paediatric patients, geriatric patients etc.); contra-
indications; warnings; precautions; drug interactions; undesirable effects;
overdose; pharmacodynamic and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information; storage and handling
instructions.
15 Proposed Draft specimen of the label and carton. The drafts of label
and carton texts should comply with provisions of Rules 96 and 97.
16 If the study drug is intended to be imported for the purposes of
examination, test or analysis, the application for import of small quantities
of drugs for such purpose should also be made in Form 12.
13. 17. STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL TRIAL PROTOCOL:
# Documents required to be submitted Status
Yes No
1. Title Page
2. Table of Contents
3. Study Objective(s) (primary as well as secondary) and their
logical relation to the study design.
4. Study Design
5. Study Population
6. Subject Eligibility - Inclusion Criteria and Exclusion Criteria
7. Study Assessments
8. Study Treatment
9. Adverse Events
10. Ethical Considerations
11. Study Monitoring and Supervision
12. Study Monitoring and Supervision
13. Investigational Product Management
14. Data Analysis
Undertaking by the Investigator: This shall include all the details /
15. elements as mentioned in the Appendix VII of Schedule-Y.
Informed consent documents (patient information sheet,
informed consent form etc.) as per Appendix V of Schedule-Y
should mention the following: “In case of study related injury or
16.
death M/s. (NAME OF THE COMPANY) will provide complete
medical care along with compensation for the injury or death”.
14. 18. Protocol of Bioequivalence study along with Informed Consent document and
undertaking by Investigator in case of Oral Dosage Forms having systematic
absorption. In case of biowaiver, justification should be submitted.
19. STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL STUDY REPORTS:
# Documents required to be submitted Status
Yes No
1. Title Page
2. Study Synopsis
3. Statement of compliance with the „Guidelines for Clinical Trials on
Pharmaceutical Products in India
4. List of Abbreviations and Definitions
5. Table of contents
6. Copy of Ethics Committee approval
7. Study Team
8. Introduction
9. Study Objective
10. Investigational Plan
11. Trial Subjects
12. Efficacy evaluation
13. Safety Evaluation
14. Discussion and overall Conclusion
15. List of References
15. Note:
1. All items mentioned above may not be applicable to all drugs. The items not relevant
to a particular new drug should be marked with “Not Applicable (NA)”.
2. Application for both bulk as well as formulation is required to be submitted. Proposal
for grant of permission to manufacture only bulk drug will be considered after approval
of it‟s formulation.
3. In case the application is for clinical trial permission:
a. Adequate chemical and pharmaceutical information should be provided to ensure
the proper identity, purity, quality & strength of the investigational product, the
amount of information needed may vary with the Phase of clinical trials, proposed
duration of trials, dosage forms and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies,
applicants should submit copy of approval of protocol, amended new protocol,
summarized list of all the new changes incorporated along with justification /
reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics
Committee located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the
country and should also include clinical sites which have their own Institutional
Ethics Committee.
-------------------------
16. 3. Application for Global Clinical Trial
CONTENT YES NO
1. Name of the Applicant:-
2. Name of the Sponsor:-
3. Authorisation Letter from Sponsor:-
4. Treasury Challan along with Form 44 (amount):-
5. Treasury Challan along with Form 12 (amount):-
6. Name of the Study Drug:-
7. Dosage form:-
8. Therapeutic class:-
9. Study Protocol:-
Phase of Study:-
10. Undertaking by the Investigators as per Appendix VII of
Schedule „y‟ :-
(Ethics Committee should be of same area where the site is
located and details of the committee should be mentioned)
11.Patient Information Sheet (PIS)/ Informed consent form (ICF) as
per Appendix V of Schedule „y‟ :-
The following clause should be added “In case of study related
injury or death, M/s (applicant) will provide complete medical
care along with compensation for the injury or death”.
12. Justification for conducting the study in India:-
13. Details of Export of Biological Samples:-
14. Application for Export NOC for biological samples:-
15. List of Investigators in India including site Address:-
16. Name of the Participating Countries:-
17. Total Number of patients to be enrolled globally:-
18. Total Number of patients to be enrolled in India:-
19. Status of Drug in India & other countries:-
20. Status of the proposed study in other participating countries:-
21. If any Clinical trial of the Investigational Product has been
Withdrawn/discontinued in any country or rejected/refused by
any RegulatoryAgency if so details of the same.
22. Approvals of the proposed protocol from other participating
countries (Notification to USFDA and IRB Approvals in case
USA is a participating country).
23. Ethics Committee approvals if available:-
(Ethics Committee should be of same area where the site is
located.)
24. Investigators Brochure:-
25. Investigational Medicinal Products Dossier (IMPD):-
25 (a) Information on active ingredients:
Drug information (Generic Name, Chemical Name or INN) &
Physicochemical
Data including:
i. Chemical name and Structure - Empirical formula, Molecular
weight
17. ii. Analytical Data: Elemental analysis, Mass spectrum, NMR
spectra, IR spectra, UV
spectra, Polymorphic identification
iii.Stability Studies: Data supporting stability in the intended
container closure system
for the duration of the clinical trial.
iv. Certificate of Analysis (COA):-
Note: While adequate chemical and pharmaceutical information
should be provided to ensure the proper identity, purity, quality &
strength of the investigational product, the amount of information
needed may vary with the Phase of clinical trials, proposed
duration of trials, dosage forms and the amount of information
otherwise available.
25 (b) Data on Formulation:
i. Dosage form
ii. Composition
iii. Master manufacturing formula
iv. Details of the formulation (including inactive ingredients)
v. In process quality control check
vi. Finished product specification & Method of Analysis
vii. Certificate of analysis
viii. Excipient compatibility study
ix. Validation of the analytical method.
x. Stability Studies: Data supporting stability in the intended
container closure system for the duration of the clinical trial.
Note: While adequate chemical and pharmaceutical information
should be provided to ensure the proper identity, purity, quality &
strength of the investigational product, the amount of information
needed may vary with the Phase of clinical trials, proposed
duration of trials, dosage forms and the amount of information
otherwise available.
26 Affidavit declaring that the information about study drug as
mentioned in
Investigators Brochure is correct and based on available facts:-
27 Affidavit declaring that the study has not been discontinued in
any country. In case of discontinuation the reasons for such a
discontinuation would be communicated:-
Technical Documents:-
1) Package Insert:- (if the drug is marketed in any country
18. 2) Pre-clinical Data:-
I. Animal Pharmacological Data:-
Summary
Specific pharmacological actions
General pharmacological actions
Follow-up and Supplemental Safety Pharmacology
Studies
Pharmacokinetics: absorption, distribution;
metabolism;Excretion
II. Animal toxicology data as per Schedule Y.
a. systemic toxicity studies,
i. single dose toxicity
ii. repeated dose toxicity
b. Male Fertility Study
c. Female Reproduction and Developmental Toxicity
Studies
d. (for all drugs proposed to be studied or used in
women of child bearing age)
e. Local toxicity
i. Dermal toxicity (for products meant for topical
(dermal) application)
ii. Ocular toxicity (for products meant for ocular
instillation)
iii. Inhalation toxicity (conducted with the formulation
proposed to be used via inhalation route)
iv. Vaginal toxicity (for products meant for topical
application to vaginal mucosa)
v. Photoallergy or dermal phototoxicity (required if
the drug or a metabolite is related to an agent
causing photosensitivity or the nature of action
suggests such a potential)
vi. Rectal tolerance test (For all preparations meant
for rectal administration)
f. Genotoxicity
g. Allergenicity/Hypersensitivity
h. Carcinogenicity (Carcinogenicity studies should be
performed for all drugs that are expected to be
clinically used for more than 6 months as well as for
drugs used frequently in an intermittent manner in
the treatment of chronic or recurrent conditions.
However, completed rodent carcinogenicity studies
are not needed in advance of the conduct of large
scale clinical trials, unless there is a special concern
for the patient population)
Reports of following toxicity studies should be submitted alongwith
clinical trial applications of different Phases for INDs:
For Phase I Clinical Trials
Systemic Toxicity studies
(i) Single dose toxicity studies
(ii) Dose Ranging Studies
19. (iii) Repeat-dose systemic toxicity studies of appropriate duration
to support the duration of proposed human exposure.
Male fertility study
In-vitro genotoxicity tests
Relevant local toxicity studies with proposed route of clinical
application (duration depending on proposed length of clinical
exposure)
Allergenicity/Hypersensitivity tests (when there is a cause for
concern or for parenteral drugs, including dermal application)
Photo-allergy or dermal photo-toxicity test (if the drug or a
metabolite is related to an agent causing photosensitivity or the
nature of action suggests such a potential)
For Phase II Clinical Trials
Provide a summary of all the non-clinical safety data (listed above)
already submitted while obtaining the permissions for Phase I trial, with
appropriate references.
In case of an application for directly starting a Phase II trial -
complete details of the non-clinical safety data needed for
obtaining the permission for Phase I trial, as per the list provided
above must be submitted.
Repeat-dose systemic toxicity studies of appropriate duration to
support the duration of proposed human exposure
In-vitro and In-vivo genotoxicity tests.
Segment II reproductive/developmental toxicity study (if female
patients of child bearing age are going to be involved)
For Phase III Clinical Trials
Provide a summary of all the non-clinical safety data (listed
above) already submitted while obtaining the permissions for
Phase I and II trials, with appropriate references.
In case of an application for directly initiating a Phase III trial -
complete details of the non-clinical safety data needed for
obtaining the permissions for Phase I and II trials, as per the list
provided above must be provided.
Repeat-dose systemic toxicity studies of appropriate duration to
support the duration of proposed human exposure
Reproductive/developmental toxicity studies
In-vitro and In-vivo genotoxicity tests.
Segment I (if female patients of child bearing age are going to be
involved), and
Segment III (for drugs to be given to pregnant or nursing mothers
or where there are indications of possible adverse effects on
foetal development).
Carcinogenicity studies (when there is a cause for concern or when the
drug is to be used for more than 6 months).
20. 3) Clinical Data:
I. Human / Clinical pharmacology (Phase I):-
Summary
Specific Pharmacological effects
General Pharmacological effects
Pharmacokinetics, absorption, distribution, metabolism,
excretion
Pharmacodynamics / early measurement of drug activity
II. Therapeutic exploratory trials (Phase II):-
Summary
Study reports
III. Therapeutic confirmatory trials (Phase III):-
Summary
Individual study reports with listing of sites and
Investigators.
Special studies:-
Summary
Bio-availability / Bio-equivalence.
Other studies e.g. geriatrics, paediatrics, pregnant or
nursing women.
4) PMS/ PSUR data (Phase IV):-
Note: Details of Animal Pharmacology & Animal Toxicology
studies required to be carried out will be as per Appendix IV &
Appendix III of Schedule Y of Drugs and Cosmetics Rules
respectively. Depending upon the nature of new drugs and
disease(s) specific additions/deletions may be made to the
above requirement.
21. 4. Checklist for Protocol Amendment (GCT )
Classification for major protocol amendment:
1. Amendment with respect to age limit of subject, dose, and treatment duration.
2. Increase in number of subjects
3. Amendment in study design
4. Amendment in inclusion or exclusion criteria
5. Amendment in safety or efficacy parameters
6. Any other changes which has impact on safety of the subject
Checklist for Major Protocol Amendment:
S.No. CONTENTS YES NO
1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Copy of the amended protocol
5. Changes made in comparison with earlier protocol to be
presented with rationale and major changes should be
highlighted
6. Safety and efficacy data in support of proposed amendment
7. Regulatory approval from participating key country/countries
(in case of language other than English, English Translated
version along with Translation Certificate)
Checklist for Minor Protocol Amendment:
S.No. CONTENTS YES NO
1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Copy of the amended protocol
5. Changes made in comparison with earlier protocol to be
presented with rationale.
22. 5. Checklist for Import License (GCT)
1. In case of fresh Test License
S.No. CONTENTS YES NO
1. Covering letter
2. TR-6 challan of required amount; bank‟s stamp for cheque
realization(a fee of one hundred rupees for asingle drug and
an additional fee of fifty rupees or each additional drug).
3. Application in Form-12, sign, date, stamp, country from
which the drugs to be imported
4. Justification for quantity to be imported
5. Copy of CT permission letter
The following additional documents need to be submitted in case of Test License of balance
quantity/ additional quantity / expiry of validity of test licence
1. Debit sheet
2. Justification for the additional quantity to be imported
23. 6. Checklist for Site Addition/ Deletion/ Closure/ Change in PI
a. Site addition
S.No. CONTENTS YES NO
1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Undertaking by the Investigators as per Appendix VII of
Schedule” Y”:-
(Ethics Committee should be of same area where the site is
located.)
5. CV/ Statement of Qualification
6. Copy of Ethics committee approval letter, if available
b. Site Closure / Deletion
S.No. CONTENTS YES NO
1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Reason for closure
5. Subject enrolment status
6. Procedure for subject follow up at the given site
7. Copy of Ethics committee notification
8. Copy of Ethics committee approval letter, if available
9. Copy of summary report
24. c. Change in Site Address
S.No. CONTENTS YES NO
1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Reason for site address change
5. Undertaking by the Investigators as per Appendix VII of
Schedule” Y”:-
(Ethics Committee should be of same area where the site is
located.)
6. CV/ Statement of Qualification
7. Copy of Ethics committee approval letter(earlier site and the
proposed site), if available
d. Change in Investigator
S.No. CONTENTS YES NO
1. Covering letter
2. Copy of CT permission letter
3. Copy of previous protocol amendment approval letter, if any
4. Reason for change of Investigator in same site
5. Undertaking from new Investigatorsas per Appendix VII of
Schedule” Y”:-
(Ethics Committee should be of same area where the site is
located.)
6. CV/ Statement of Qualification
7. Copy of Ethics committee approval letter, if available
25. 7. Checklist for Grant of permission to manufacture/import of Bulk Drug already
approved in the country
# Documents required to be submitted Status
Yes No
1. Name of Applicant
2. Name of Drug
3. Therapeutic Class
4. Date of Approval
5. Application in Form-44duly filled and signed by the
competent authority
6. Treasury Challan of Rs. 50,000/- upto 1 year from initial
approval and Rs. 15,000/- for other drugs upto 4 years
7A. For manufacturing:-
Copy of manufacturing license in Form-25/ Form-26 for
any bulk drug to manufacturer and Form-29
7B. For import:-
Copy of drug sale license in Form 20B and 21B
8. Pharmaceutical & Chemical Information
8A. Manufacturing Process including in process control
8B. Specifications and methods of analysis
8C. Structural elucidation data
9. Sub-acute toxicity data generated with the applicant „s bulk
drug in two species
10. Stability data of three different lots as per Schedule –Y of
Drugs and Cosmetics Rules
11. CDTL Test report
* In case the application is for grant of NOC for lab testing the documents at serial no 9 & 10
may be submitted at the time of approval of bulk drug.
26. 8. Approvals of a New drug (Formulation) already approved in the
country
# Documents required to be submitted Enclosed
Yes No
1. Application for permission to Manufacture /Import:
(Purpose should be mentioned clearly)
2. Name of the applicant
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by
authorized personal
6. Treasury Challan of INR 15,000 New Drug approved in
India for more than one year, or INR 50,000 of New Drug is
approved for less than one year duly signed and stamped
by Bank of Baroda
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. Source of bulk drugs along with current regulatory status of
the source with copy of Form 46A/45A. (if obtained)
10. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) Specifaction
c) Method of Analysis
d) Certificate of Analysis
11. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure
c) Finished product specification
d) Finished product Method of Analysis
e) Finished product Certificate of Analysis
f) In process quality control check
g) Stability study data evaluation as per requirements of
schedule Y
h) Dissolution Release Profile (in case of oral dosage form)
i) Copy of proposed Package Insert which should include
generic name of all active ingredients; composition; dosage
form/s, indications; dose and method of administration; use in
special populations; contraindications; warnings; precautions;
drug interactions; undesirable effects; overdose;
pharmacodynamic and pharmacokinetic properties;
incompatibilities; shelf-life; packaging information; storage
and handling instructions.
27. j) Draft specimen of Label and Carton
12. Bio Equivalence study Protocol in case BE Permission / BE
report in case of Final approval. ( for oral dosage form.)
12.1. Justification on Bio equivalance study waiver, if requested
13. In case of injectable formulation, sub-acute toxicity data
conducted with the applicant drug formulation.
Note :
In case the application is for clinical trial / Bio equivalence permission:
a. Adequate chemical and pharmaceutical information should be provided to ensure the proper identity,
purity, quality & strength of the investigational product, the amount of information needed may vary
with the Phase of clinical trials, proposed duration of trials, dosage forms and the amount of
information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants should
submit copy of approval of protocol, amended new protocol, summarized list of all the new changes
incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee located in
the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the country and
should also include clinical sites which have their own Institutional Ethics Committee.
28. 9. A drug already approved by the Licensing Authority mentioned in Rule 21 proposed
to be marketed with new indication
# Documents required to be submitted Enclosed
Yes No
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for
less than one year and not submitted challan earlier for the same
drug.
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. In case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (if
obtained)
10. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) Specifaction
c) Method of Analysis
d) Certificate of Analysis
11. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure
c) Finished product specification
d) Finished product Method of Analysis
e) Finished product Certificate of Analysis
f) In process quality control check
g) Stability study evaluation as per requirements of schedule Y
h) Dissolution Release Profile (in case of oral dosage form)
i) Copy of proposed Package Insert which should include generic
name of all active ingredients; composition; dosage form/s,
indications; dose and method of administration; use in special
populations; contraindications; warnings; precautions; drug
interactions; undesirable effects; overdose; pharmacodynamic and
pharmacokinetic properties; incompatibilities; shelf-life; packaging
information; storage and handling instructions.
j) Draft specimen of Label and Carton
Sr No 9 to 11 is not applicable, if applicant holds manufacturing or Import and
marketing permission for the proposed drug product [ Except 11(i) and 11(j)]
12. Therapeutic Rationale and justification for the proposed
Additional Indication
29. 13. Regulatory status in other countries, as appropriate.
a) Names of the countries where the the drug is
marketed/approved for proposed indication alongwith
package insert and/or copies of approval in key countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
14 Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Ckecklist alredy given in New
Drug application)
15 Justification on Clinical trial waiver, if requested.
16 Published report of Clinical trial/Journel/literature with respect to
proposed Additional Indication.
Note :
In case the application is for clinical trial / Bio equivalence permission:
a. Adequate chemical and pharmaceutical information should be provided to ensure the proper identity,
purity, quality & strength of the investigational product, the amount of information needed may vary
with the Phase of clinical trials, proposed duration of trials, dosage forms and the amount of
information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants should
submit copy of approval of protocol, amended new protocol, summarized list of all the new changes
incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee located in
the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the country and
should also include clinical sites which have their own Institutional Ethics Committee.
30. 10. A drug already approved by the Licensing Authority mentioned in Rule 21 and
proposed to be marketed as a ‘New Dosage Form / New Route of
Administration’.
# Documents required to be submitted Enclosed
Yes No
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant
3. Name of the New Drug
a. Composition of the New Drug
b. Proposed Dosage Form
c. Proposed indication for the New Drug
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form and route of adminstration
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for
less than one year and not submitted challan earlier for the same
drug.
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. In case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (if
obtained)
10. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) Specifaction
c) Method of Analysis
d) Certificate of Analysis
11. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure
c) Finished product specification
d) Finished product Method of Analysis
e) Finished product Certificate of Analysis
f) In process quality control check
g) Stability study evaluation as per requirements of schedule Y
h) Dissolution Release Profile (in case of oral dosage form)
i) Copy of proposed Package Insert which should include generic
name of all active ingredients; composition; dosage form/s,
indications; dose and method of administration; use in special
populations; contraindications; warnings; precautions; drug
interactions; undesirable effects; overdose; pharmacodynamic and
pharmacokinetic properties; incompatibilities; shelf-life; packaging
information; storage and handling instructions.
j) Draft specimen of Label and Carton
12 Therapeutic Rationale and justification for the proposed
new dosage form / new route of administration
31. 13. Regulatory status in other countries, as appropriate.
a) Names of the countries where the the drug is
marketed/approved for proposed Dosage Form / New
Route of Administration alongwith package insert and/or
copies of approval in key countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
14 Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Ckecklist alredy given in New
Drug application)
15 Bio Equivalence study requirement (in case of oral dosage form
as appropriate as per Appendix X of Schedule Y)
16 Justification on Clinical trial and Bio equivalance study waiver, if
requested.
17 Animal toxicology data as per Schedule Y.
o. Systemic toxicity studies,
i. single dose toxicity
ii. repeated dose toxicity
p. Local toxicity
a. Dermal toxicity (for products meant for topical
(dermal) application)
b. Ocular toxicity (for products meant for ocular
instillation)
c. Inhalation toxicity (conducted with the formulation
proposed to be used via inhalation route)
d. Vaginal toxicity (for products meant for topical
application to vaginal mucosa)
e. Photoallergy or dermal phototoxicity (required if the
drug or a metabolite is related to an agent causing
photosensitivity or the nature of action suggests such a
potential)
f. Rectal tolerance test (For all preparations meant for
rectal administration)
18 Published report of Clinical trial/Journal/literature with respect to
proposed Dosage Form / New Route of Administration.
32. 11. A drug already approved by the Licensing Authority mentioned in Rule 21 now
proposed to be marketed as a ‘Modified release dosage form’.
# Documents required to be submitted Enclosed
Yes No
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved indication
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for
less than one year and not submitted challan earlier for the same
drug.
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. In case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (if
obtained)
10. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) Specifaction
c) Method of Analysis
d) Certificate of Analysis
11. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure
c) Finished product specification
d) Finished product Method of Analysis
e) Finished product Certificate of Analysis
f) In process quality control check
g) Stability study evaluation as per requirements of schedule Y
h) Dissolution Release Profile (in case of oral dosage form)
i) Copy of proposed Package Insert which should include generic
name of all active ingredients; composition; dosage form/s,
indications; dose and method of administration; use in special
populations; contraindications; warnings; precautions; drug
interactions; undesirable effects; overdose; pharmacodynamic and
pharmacokinetic properties; incompatibilities; shelf-life; packaging
information; storage and handling instructions.
j) Draft specimen of Label and Carton
12 Therapeutic Rationale and justification for the proposed
new dosage form / new route of administration
33. 13. Regulatory status in other countries, as appropriate.
a) Names of the countries where the the drug is
marketed/approved for proposed Modified Dosage Form
alongwith package insert and/or copies of approval in key
countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
14. Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Ckecklist alredy given in New
Drug application)
15 Bio Equivalence study requirement (in case of oral dosage form
as appropriate as per Appendix X of Schedule Y)
16 Justification on Clinical trial and Bio equivalance study waiver, if
requested.
17. Published report of Clinical trial/Journal/literature with respect to
proposed Modified Dosage Form.
Note :
In case the application is for clinical trial / Bio equivalence permission:
a. Adequate chemical and pharmaceutical information should be provided to ensure the proper identity,
purity, quality & strength of the investigational product, the amount of information needed may vary
with the Phase of clinical trials, proposed duration of trials, dosage forms and the amount of
information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants should
submit copy of approval of protocol, amended new protocol, summarized list of all the new changes
incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee located in
the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the country and
should also include clinical sites which have their own Institutional Ethics Committee.
34. 12. A drug already approved by the Licensing Authority mentioned in Rule 21
proposed to be marketed with Additional Strength
# Documents required to be submitted Enclosed
Yes No
1. Application for permission to Manufacture /Import/Clinical
trial: (Purpose should be mentioned clearly)
2. Name of the applicant
3. Name of the New Drug
a. Composition of the New Drug
b. Dosage Form
c. Proposed indication for the New Drug
4. Details of the approval of the New Drug in the country
a. Approved Dosage Form
b. Approved composition
c. Approved Strength along with Indiaction
5. Application in Form 44 duly signed and stamped by authorized
personal
6. Treasury Challan of INR 15,000 New Drug approved in India for
more than one year, or INR 50,000 of New Drug is approved for
less than one year and not submitted challan earlier for the same
drug.
7. Copy of valid manufacturing license in Form 25/28/26
8. Copy of Test license in form 29
9. in case of new drug, Source of bulk drugs along with current
regulatory status of the source with copy of Form 46A/45A. (If
obtained)
10. Information on active ingredients:
a) Brief Chemical & pharmaceutical data
b) Specifaction
c) Method of Analysis
d) Certificate of Analysis
11. Data on Formulation
a) Master manufacturing formula
b) Manufacturing Procedure
c) Finished product specification
d) Finished product Method of Analysis
e) Finished product Certificate of Analysis
f) In process quality control check
g) Stability study evaluation as per requirements of schedule Y
h) Dissolution Release Profile (in case of oral dosage form)
i) Copy of proposed Package Insert which should include generic
name of all active ingredients; composition; dosage form/s,
indications; dose and method of administration; use in special
populations; contraindications; warnings; precautions; drug
interactions; undesirable effects; overdose; pharmacodynamic and
pharmacokinetic properties; incompatibilities; shelf-life; packaging
information; storage and handling instructions.
j) Draft specimen of Label and Carton
12. Therapeutic Rationale and justification for the proposed
Additional Strength
35. 13 Regulatory status in other countries, as appropriate.
a) Names of the countries where the the drug is
marketed/approved for proposed additional strength
alongwith package insert and/or copies of approval in key
countries.
b) Names of the countries where the drug is withdrawn, if
any, with reasons
c) Free sale certificate (FSC) or Certificate of
Pharmaceutical Product (COPP), in case of import.
14 Clinical trial protocol in case of proposed Additional dosage form
is not approved in key countries. (Ckecklist alredy given in New
Drug application)
15 Bio Equivalence study requirement (in case of oral dosage form
as appropriate as per Appendix X of Schedule Y)
16 Justification on Clinical trial and Bio equivalance study waiver, if
requested.
17 Published report of Clinical trial/Journel/literature with respect to
proposed Additional Strength.
Note :
In case the application is for clinical trial / Bio equivalence permission:
a. Adequate chemical and pharmaceutical information should be provided to ensure the
proper identity, purity, quality & strength of the investigational product, the amount of
information needed may vary with the Phase of clinical trials, proposed duration of trials,
dosage forms and the amount of information otherwise available.
b. In case of applications for protocol amendments of already approved studies, applicants
should submit copy of approval of protocol, amended new protocol, summarized list of
all the new changes incorporated along with justification / reasons for the change.
c. Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial study centres should be geographically distributed in the
country and should also include clinical sites which have their own Institutional Ethics
Committee.
36. 13. Application for BE NOC for Export, of a new molecule not approved in
India but approved in the other countries.
S. Documents Yes No
No
1 Application in Form-44 duly signed, stamped & dated by the
competent authority with name and designation.
2 Treasury Challan: Rs 25000/- BE NOC & T/L (Brand Name &
Generic Name of the drug in form 12)
3 A copy of the approval granted to the BE study centre by
CDSCO
4 Regulatory status of the drug in other country
5 Names of the countries where the drug is currently being
marketed (to be mentioned in the covering letter also)
6 Prescribing information/Package literature on the international
product
7 Chemical & Pharmaceutical data including stability data
8 Non-clinical & clinical data as per Appendix- I of schedule Y
along with Published data BA/BE study carried out in healthy
volunteers
9 In the case of multiple dose BE study adequate supporting
safety data including published report of BA/BE carried out in
the subjects.
10 Sponsor‟s Authorization letter duly signed by the competent
authority on their letterhead.
11 Undertaking by the Principal Investigator (PI) as per appendix
VII of schedule “Y” of Drugs and Cosmetic Rules.
12 The study synopsis
13 The study protocols
14 Complete Informed consent form/Patient Information Sheet
Informed consent Documents should include “in case of study
related injury the (name of the applicant) will provide complete
medical care along with compensation for injury”. Further
compensation for participation in the study should be paid to
the volunteers proportionately at the end of each period of the
study.
IEC Location : /study site location :
The Location of Ethics committee vis-a-vis location of the
study site
Authority under which ethics committee has been
37. constituted.
Composition of Ethics committee
Review and decision making process of the Ethics
committee.
Source and methods of recruitment for volunteers
ICF process followed for the study
*The above information is not required if the information
already submitted earlier with application, However the firm
should mention the reference of the submission.
15 Complete Certificate of Analysis of same batches (both test &
reference formulations) to be used in the BE study along with
dissolution profile.
16 In the case of Injectable preparation the sub-acute toxicity
should be submitted on the product of the sponsor, generated
in two species for adequate duration.
17 Depending on the nature of the drug like cytoxic agent,
hormonal preparations etc. Proper justification for conducting
studies on healthy volunteers/patients or male/ female should
be submitted, published report of BA/BE carried out in the
subjects.
38. 14.Application for BE NOC for Export, of a New Drugs approved in India within
period of 1 year:-
S. Documents Yes No
No
1 Application in Form-44 duly signed, stamped & dated by the
competent authority with name and designation.
2 Treasury Challan: Rs 25000/- BE Noc & T/L (Brand Name &
Generic Name of the drug in form 12)
3 A copy of the approval granted to the BE study centre by CDSCO
4 Regulatory status of the drug in India
6 Published data BA/BE study carried out in healthy volunteers
7 Sponsor‟s Authorization letter duly signed by the competent
authority on their letterhead.
8 Undertaking by the Principal Investigator (PI) as per appendix VII of
schedule “Y” of Drugs and Cosmetic Rules.
9 The study synopsis
10 The study protocols
11 Complete Informed consent form/Patient Information Sheet
Informed consent Documents should include “in case of study
related injury the (name of the applicant) will provide complete
medical care along with compensation for injury”. Further
compensation for participation in the study should be paid to the
volunteers proportionately at the end of each period of the study.
IEC Location : /study site location :
The Location of Ethics committee vis-a-vis location of the study site
Authority under which ethics committee has been constituted.
Composition of Ethics committee
Review and decision making process of the Ethics
committee.
Source and methods of recruitment for volunteers
ICF process followed for the study
*The above information is not required if the information already
submitted earlier with application, However the firm should mention
the reference of the submission.
12 Chemical & Pharmaceutical data including stability data, Complete
Certificate of Analysis of same batches (both test & reference
formulations) to be used in the BE study along with dissolution
profile.
13 In the case of multiple dose BE study adequate supporting safety
39. data including published report of BA/BE carried out in the
subjects.
14 In the case of Injectable preparation the sub-acute toxicity should
be submitted on the product of the sponsor, generated in two
species for adequate duration.
15 Depending on the nature of the drug like cytoxic agent, hormonal
preparations etc. Proper justification for conducting studies on
healthy volunteers/patients or male/ female should be submitted.
16 If the study is proposed with new dosage form, new route of
administration, higher strength of the drug, supporting safety data
including published report of BA/BE carried out in the subjects.
40. 15. Application for BE NOC for Export, of a New Drugs approved within period
of more than 1 year & less than 4 years:
S. Documents Yes No
No
1 Application in Form-44 duly signed, stamped & dated by the
competent authority with name and designation.
2 Treasury Challan: Rs15000/- BE Noc & T/L (Brand Name &
Generic Name of the drug in form 12)
3 A copy of the approval granted to the BE study centre by CDSCO
4 Regulatory status of the drug in India
5 Sponsor‟s Authorization letter duly signed by the competent
authority on their letterhead.
6 Undertaking by the Principal Investigator (PI) as per appendix VII of
schedule “Y” of Drugs and Cosmetic Rules.
7 The study synopsis
8 The study protocols
9 Complete Informed consent form/Patient Information Sheet
Informed consent Documents should include “in case of study
related injury the (name of the applicant) will provide complete
medical care along with compensation for injury”. Further
compensation for participation in the study should be paid to the
volunteers proportionately at the end of each period of the study.
IEC Location : /study site location :
The Location of Ethics committee vis-a-vis location of the study site
Authority under which ethics committee has been constituted.
Composition of Ethics committee
Review and decision making process of the Ethics
committee.
Source and methods of recruitment for volunteers
ICF process followed for the study
*The above information is not required if the information already
submitted earlier with application, However the firm should mention
the reference of the submission.
10 Chemical & Pharmaceutical data including stability data, Complete
Certificate of Analysis of same batches (both test & reference
formulations) to be used in the BE study along with dissolution
profile.
11 In the case of multiple dose BE study adequate supporting safety
data including published report of BA/BE carried out in the
41. subjects.
12 In the case of Injectable preparation the sub-acute toxicity should
be submitted on the product of the sponsor, generated in two
species for adequate duration.
13 Depending on the nature of the drug like cytoxic agent, hormonal
preparations etc. Proper justification for conducting studies on
healthy volunteers/patients or male/ female should be submitted.
14 If the study is proposed with new dosage form, new route of
administration, higher strength of the drug, supporting safety data
including published report of BA/BE carried out in the subjects.
42. 16. Application for BE NOC for Export, of a drug product in modified release
form irrespective of their approval status:-
S. Documents Yes No
No
1 Application in Form-44 duly signed, stamped & dated by the
competent authority with name and designation.
2 Treasury Challan: Rs 15000/- BE NOC & T/L (Brand Name &
Generic Name of the drug in form 12)
3 A copy of the approval granted to the BE study centre by CDSCO
4 Regulatory status of the drug in India
5 Sponsor‟s Authorization letter duly signed by the competent
authority on their letterhead.
6 Undertaking by the Principal Investigator (PI) as per appendix VII of
schedule “Y” of Drugs and Cosmetic Rules.
7 The study synopsis
8 The study protocols
9 Complete Informed consent form/Patient Information Sheet
Informed consent Documents should include “in case of study
related injury the (name of the applicant) will provide complete
medical care along with compensation for injury”. Further
compensation for participation in the study should be paid to the
volunteers proportionately at the end of each period of the study.
IEC Location : /study site location :
The Location of Ethics committee vis-a-vis location of the study site
Authority under which ethics committee has been constituted.
Composition of Ethics committee
Review and decision making process of the Ethics
committee.
Source and methods of recruitment for volunteers
ICF process followed for the study
*The above information is not required if the information already
submitted earlier with application, However the firm should mention
the reference of the submission.
10 Chemical & Pharmaceutical data including stability data, Complete
Certificate of Analysis of same batches (both test & reference
formulations) to be used in the BE study along with dissolution
profile.
11 In the case of multiple dose BE study adequate supporting safety
data should be submitted.
43. 12 In the case of Injectable preparation the sub-acute toxicity should
be submitted on the product of the sponsor, generated in two
species for adequate duration.
13 Depending on the nature of the drug like cytoxic agent, hormonal
preparations etc. Proper justification for conducting studies on
healthy volunteers/patients or male/ female should be submitted.
14 If the study is proposed with new dosage form, new route of
administration, higher strength of the drug, supporting safety data
including published report of BA/BE carried out in the subjects.
****************