This document provides an overview of pain management technologies and treatments, with a focus on abuse-deterrent formulations of opioids. It discusses the FDA's efforts to address the opioid epidemic through new guidelines for abuse-deterrent drugs and formulations. Several approved and pipeline abuse-deterrent opioid formulations are described, along with their drug delivery technologies. Emerging non-opioid treatments for pain including new drug targets and mechanisms of action are also reviewed, which may help reduce opioid use. The document aims to analyze the impact of regulatory changes and new technologies on the opioid drug market in both the US and Europe.
The International Conference on Harmonisation (ICH) is a joint initiative involving regulators from Europe, Japan, and the United States along with research-based pharmaceutical companies to discuss scientific and technical requirements for drug approval. The goal of ICH is to harmonize these requirements to ensure safe and effective drugs are approved efficiently. ICH has created guidelines on topics like good clinical practice, quality assurance, efficacy, and safety that are followed by regulatory agencies worldwide.
IMPACT OF REGULATIONS ON MEDICAL DEVICES IN CONTEXT OF INNOVATIONSJAYA PRAKASH VELUCHURI
The document discusses the impact of regulations on innovation in the medical devices sector. It provides background on regulations in the United States and European Union, which classify devices based on risk and require clinical trials and quality standards. Regulations influence the entire innovation cycle from design to post-market surveillance. While regulations aim to ensure safety, they can also introduce barriers and uncertainty that slow innovation. Emerging technologies like nanomaterials and 3D bioprinting further complicate classification and evaluation. The document argues for collaboration between developers and regulators to streamline processes while encouraging innovation and access to new treatments.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The document provides an overview of the World Health Organization (WHO) and key regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) of India and the U.S. Food and Drug Administration (FDA). It discusses the roles, structures and functions of WHO in global health governance and national regulatory bodies like CDSCO and FDA in ensuring safety and efficacy of drugs, medical devices and other products. Major sections include organizational structure of WHO, priorities, achievements and challenges. For CDSCO and FDA, it summarizes their roles in approval of new drugs and devices, good manufacturing practices, and enforcement.
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.
AN OVERVIEW ON FIXED DOSE COMBINATIONS AND ITS REGULATIONS IN INDIA JAYA PRAKASH VELUCHURI
This document provides an overview of fixed dose combination drugs and regulatory requirements for FDCs in India. It discusses the classification of FDCs, clinical trial requirements, bioavailability and bioequivalence data requirements. It also addresses the reasons why 328 FDCs were banned in India, including that they were found to have no therapeutic justification and safer alternatives were available. Success factors for FDCs include addressing formulation challenges, patent feasibility, and physician considerations.
The document discusses regulatory bodies and processes related to drugs in the United States and Canada. It provides information on the organization and functions of the US Food and Drug Administration (FDA), including the Federal Register, Code of Federal Regulations, and history of the Federal Food, Drug, and Cosmetic Act. It also discusses the Hatch-Waxman Act, Orange Book, Purple Book, and Drug Master File system in the US.
The International Conference on Harmonisation (ICH) is a joint initiative involving regulators from Europe, Japan, and the United States along with research-based pharmaceutical companies to discuss scientific and technical requirements for drug approval. The goal of ICH is to harmonize these requirements to ensure safe and effective drugs are approved efficiently. ICH has created guidelines on topics like good clinical practice, quality assurance, efficacy, and safety that are followed by regulatory agencies worldwide.
IMPACT OF REGULATIONS ON MEDICAL DEVICES IN CONTEXT OF INNOVATIONSJAYA PRAKASH VELUCHURI
The document discusses the impact of regulations on innovation in the medical devices sector. It provides background on regulations in the United States and European Union, which classify devices based on risk and require clinical trials and quality standards. Regulations influence the entire innovation cycle from design to post-market surveillance. While regulations aim to ensure safety, they can also introduce barriers and uncertainty that slow innovation. Emerging technologies like nanomaterials and 3D bioprinting further complicate classification and evaluation. The document argues for collaboration between developers and regulators to streamline processes while encouraging innovation and access to new treatments.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The document provides an overview of the World Health Organization (WHO) and key regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) of India and the U.S. Food and Drug Administration (FDA). It discusses the roles, structures and functions of WHO in global health governance and national regulatory bodies like CDSCO and FDA in ensuring safety and efficacy of drugs, medical devices and other products. Major sections include organizational structure of WHO, priorities, achievements and challenges. For CDSCO and FDA, it summarizes their roles in approval of new drugs and devices, good manufacturing practices, and enforcement.
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.
AN OVERVIEW ON FIXED DOSE COMBINATIONS AND ITS REGULATIONS IN INDIA JAYA PRAKASH VELUCHURI
This document provides an overview of fixed dose combination drugs and regulatory requirements for FDCs in India. It discusses the classification of FDCs, clinical trial requirements, bioavailability and bioequivalence data requirements. It also addresses the reasons why 328 FDCs were banned in India, including that they were found to have no therapeutic justification and safer alternatives were available. Success factors for FDCs include addressing formulation challenges, patent feasibility, and physician considerations.
The document discusses regulatory bodies and processes related to drugs in the United States and Canada. It provides information on the organization and functions of the US Food and Drug Administration (FDA), including the Federal Register, Code of Federal Regulations, and history of the Federal Food, Drug, and Cosmetic Act. It also discusses the Hatch-Waxman Act, Orange Book, Purple Book, and Drug Master File system in the US.
The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
The document discusses the FDA drug approval process and lists some drugs that have been withdrawn by the FDA. It describes the multi-phase approval process including pre-clinical testing in animals, followed by three phases of clinical trials in humans. It can take over a decade for a drug to be approved. Several drugs are mentioned that were withdrawn from the market due to serious safety issues discovered after approval, such as thalidomide causing birth defects, phenformin causing fatal lactic acidosis, and rofecoxib increasing heart attack and stroke risk.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
This document provides a history of pharmacovigilance and discusses key aspects of the field. It begins with important milestones in drug safety regulation dating back to the early 20th century. It then defines pharmacovigilance and describes stakeholders, methods used like individual case safety reporting, and the roles of organizations like the WHO and national regulatory authorities. The document emphasizes the importance of post-market drug safety monitoring to protect public health.
Clinical evidence for medicinal cannabis reportRoby Zomer
A Report Developed by the University of Sydney
Community Placement Program in Partnership with
MGC Pharmaceuticals, In recent years, medicinal cannabis has gone from being a niche and obscure area of medical scientific research into “one of the fastest moving frontiers in pharmacology”.
The potential value of cannabis as medicine has been demonstrated in relation to a number of serious conditions and symptoms including cancer, epilepsy, multiple sclerosis, chronic pain, muscle spasticity and nausea. The clinical evidence regarding medicinal cannabis has received less attention
than it merits, and scientists, clinicians, patients and carers seeking access to this evidence have found it difficult to separate good research from the wealth of anecdotal and less rigorously obtained experimental results. This report aims to summarise the strongest available scientific research on the use of cannabis as a
medicine for the treatment of epilepsy, cancer and multiple sclerosis; the symptoms of these conditions; and the side-effects of their current treatment.
The document discusses the future of the pharmaceutical industry through examining three levels - the inner level of pharmaceutical science/R&D, middle level of business environment, and outer level of healthcare context. For the inner level, it outlines advances in areas like stem cells, medical devices, and personalized medicine. The middle level may see new business models through increased cooperation. For the outer level, it notes how patients are becoming more informed and active in decision making. The document concludes that while the future is difficult to predict, the industry must balance its missions with maintaining public trust.
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
This document defines combination products and medical devices and discusses their classification and regulatory requirements. Combination products involve two or more regulated products combined in a single package. Medical devices are instruments or articles used for diagnosis, prevention, monitoring or treatment of disease. The document outlines the classification of medical devices into Classes I-III based on risk and the regulatory pathways of 510(k), reclassification, product development protocol, de novo review, and premarket approval.
Overview regulatory environment in usa,europe,indiashabana parveen
The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
ASEAN was established in 1967 by 5 countries and has since expanded to include 10 member countries. Singapore regulates pharmaceutical products under the Medicines Act and Health Products Act to ensure safety, quality and efficacy. The regulatory process for medicines involves submitting an application to the Health Sciences Authority, which evaluates the application and issues a regulatory decision of approval, approvable, non-approvable, or rejection.
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.
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.
1)spontanious reporting schemes for biodrug adverse reactionsNeha Suresh
This document discusses sources of reports on adverse reactions to herbal drugs, herbal products targeted for safety monitoring, and reporting of suspected adverse drug reactions. The main sources of reports are healthcare professionals, consumers, and manufacturers. Herbal products can be categorized based on their regulatory status and marketing status. Only certain professionals can report adverse reactions, and reports should include identification information, herbal product details, adverse reaction data, other medication use, and the reporter's contact information. A single reporting form should be used to submit reports via various methods.
Regulatory affairs is the interface between pharmaceutical companies and government regulatory agencies. It involves activities related to drug research, development, manufacturing, registration, evaluation, authorization, distribution, pricing, advertising, and post-marketing surveillance. Regulatory affairs professionals ensure compliance with relevant regulations and guidelines from agencies like the FDA, EMA, and other national authorities. They prepare and submit regulatory dossiers containing technical data to obtain approval for new drugs or changes to approved drugs. Common elements of dossiers include quality summaries, non-clinical and clinical study reports, chemistry and manufacturing information, and regional prescribing information.
Schedule Y outlines the regulatory requirements for conducting clinical trials in India. It provides guidelines on applying for trial approval, sponsor and investigator responsibilities, informed consent, trial phases and types of studies. The document discusses amendments made to Schedule Y over time to align it more closely with ICH-GCP guidelines. It also describes the 11 appendices that provide details on topics like pre-clinical data submission, animal studies, ethics committee composition, serious adverse event reporting, and stability testing. The goal of Schedule Y is to improve clinical trial quality and ensure data standards are globally accepted.
Regulatory affairs ensures that pharmaceutical products meet legislative requirements by studying scientific and legal documents, gathering and organizing submission documents, and collating information for regulatory authorities. The Common Technical Document format is used for new drug applications and provides a harmonized structure for applications submitted to agencies like the US FDA and EMA. The US FDA filing process involves applications like Investigational New Drug Applications, New Drug Applications, and Abbreviated New Drug Applications for generic drugs. Regulatory authorities differ between fully regulated markets and semi-regulated markets.
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.
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
The document provides information on the regulatory approval process for drugs. It discusses the various stages of approval including investigational new drug applications (IND), new drug applications (NDA), and abbreviated new drug applications (ANDA).
The stages include pre-clinical testing, clinical trials through multiple phases, and regulatory review and approval. An IND must be approved by the FDA before clinical trials in humans can begin. If clinical trials are successful, manufacturers can file an NDA to request approval to market the drug. For generic drugs, an ANDA can be filed to demonstrate bioequivalence to an existing approved drug, without needing to re-conduct clinical trials. The approval process is complex and lengthy, usually taking 10-
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...JAYA PRAKASH VELUCHURI
This document summarizes a review of clinical trial evidence for metformin fixed-dose combinations (FDCs) used to treat type 2 diabetes in India. The review found:
- Only 25 relevant clinical trials were identified, with most comparing metformin FDCs to monotherapy rather than the individual components.
- None of the trials met all of the WHO's criteria for size, duration, design, and assessing adverse reactions.
- Only 3 trials were conducted in India, with one including just 101 patients over 2 months.
- Despite a lack of robust evidence, over 50 metformin FDCs have been approved in India. The document calls for Indian regulators to make their review and approval evidence public, and to strengthen clinical trial requirements
This document outlines requirements and guidelines for importing or manufacturing new drugs in India according to Drugs and Cosmetics Rules. It defines key terms like new drug, clinical trial, adverse events and reactions. It describes application procedures for new drug development and permissions under Form 44. Responsibilities of sponsors, investigators and ethics committees are provided. Important considerations for human clinical pharmacology, periodic safety update reports, label and carton drafting, and bioequivalence studies are highlighted.
Schedule Y provides requirements and guidelines for permission to import and manufacture new drugs for sale or to undertake clinical trials in India. It outlines the application process and requirements, including pre-clinical data that must be submitted. It describes the responsibilities of sponsors, investigators, and ethics committees for clinical trials. Clinical trials must progress through Phases I-IV and special population studies may be required. Post-marketing surveillance is also addressed. The purpose is to regulate new drugs and ensure clinical research is properly conducted according to good clinical practice standards.
This document summarizes trends shaping workers' compensation medication policies in 2014. It discusses the influence of various factors, including political influences from the Affordable Care Act and state elections; clinical influences like an aging population and the opioid epidemic; and product influences as new medications enter the market. It also outlines debates around issues like physician dispensing, compounded medications, medical marijuana, and opioid monitoring programs.
Epilepsy Drugs Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Op...IMARC Group
The global epilepsy drugs market size reached US$ 2.3 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 4.4 Billion by 2032, exhibiting a growth rate (CAGR) of 7.16% during 2024-2032.
More Info:- https://www.imarcgroup.com/epilepsy-drugs-market
The International Council for Harmonisation (ICH) is a joint regulatory-industry initiative to harmonize technical requirements for pharmaceutical product registration. It aims to reduce duplication of testing by achieving greater harmonization in guidelines' interpretation between Europe, Japan, and the United States. ICH addresses safety, quality, efficacy, and other topics through guidelines developed by expert working groups representing regulators and industry. Over two decades, ICH has successfully harmonized guidelines through scientific consensus.
The document discusses the FDA drug approval process and lists some drugs that have been withdrawn by the FDA. It describes the multi-phase approval process including pre-clinical testing in animals, followed by three phases of clinical trials in humans. It can take over a decade for a drug to be approved. Several drugs are mentioned that were withdrawn from the market due to serious safety issues discovered after approval, such as thalidomide causing birth defects, phenformin causing fatal lactic acidosis, and rofecoxib increasing heart attack and stroke risk.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
This document provides a history of pharmacovigilance and discusses key aspects of the field. It begins with important milestones in drug safety regulation dating back to the early 20th century. It then defines pharmacovigilance and describes stakeholders, methods used like individual case safety reporting, and the roles of organizations like the WHO and national regulatory authorities. The document emphasizes the importance of post-market drug safety monitoring to protect public health.
Clinical evidence for medicinal cannabis reportRoby Zomer
A Report Developed by the University of Sydney
Community Placement Program in Partnership with
MGC Pharmaceuticals, In recent years, medicinal cannabis has gone from being a niche and obscure area of medical scientific research into “one of the fastest moving frontiers in pharmacology”.
The potential value of cannabis as medicine has been demonstrated in relation to a number of serious conditions and symptoms including cancer, epilepsy, multiple sclerosis, chronic pain, muscle spasticity and nausea. The clinical evidence regarding medicinal cannabis has received less attention
than it merits, and scientists, clinicians, patients and carers seeking access to this evidence have found it difficult to separate good research from the wealth of anecdotal and less rigorously obtained experimental results. This report aims to summarise the strongest available scientific research on the use of cannabis as a
medicine for the treatment of epilepsy, cancer and multiple sclerosis; the symptoms of these conditions; and the side-effects of their current treatment.
The document discusses the future of the pharmaceutical industry through examining three levels - the inner level of pharmaceutical science/R&D, middle level of business environment, and outer level of healthcare context. For the inner level, it outlines advances in areas like stem cells, medical devices, and personalized medicine. The middle level may see new business models through increased cooperation. For the outer level, it notes how patients are becoming more informed and active in decision making. The document concludes that while the future is difficult to predict, the industry must balance its missions with maintaining public trust.
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
This document defines combination products and medical devices and discusses their classification and regulatory requirements. Combination products involve two or more regulated products combined in a single package. Medical devices are instruments or articles used for diagnosis, prevention, monitoring or treatment of disease. The document outlines the classification of medical devices into Classes I-III based on risk and the regulatory pathways of 510(k), reclassification, product development protocol, de novo review, and premarket approval.
Overview regulatory environment in usa,europe,indiashabana parveen
The document summarizes the process for clinical research and drug approval by the FDA. It describes the multi-step process including pre-clinical research in animals, Phase 1-3 clinical trials in humans to test safety and efficacy, and the submission of a New Drug Application. The FDA rigorously reviews data at each stage before approving progression to the next stage to ensure safety. The overall process aims to establish that new drugs are safe and effective for use by the American public.
ASEAN was established in 1967 by 5 countries and has since expanded to include 10 member countries. Singapore regulates pharmaceutical products under the Medicines Act and Health Products Act to ensure safety, quality and efficacy. The regulatory process for medicines involves submitting an application to the Health Sciences Authority, which evaluates the application and issues a regulatory decision of approval, approvable, non-approvable, or rejection.
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.
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.
1)spontanious reporting schemes for biodrug adverse reactionsNeha Suresh
This document discusses sources of reports on adverse reactions to herbal drugs, herbal products targeted for safety monitoring, and reporting of suspected adverse drug reactions. The main sources of reports are healthcare professionals, consumers, and manufacturers. Herbal products can be categorized based on their regulatory status and marketing status. Only certain professionals can report adverse reactions, and reports should include identification information, herbal product details, adverse reaction data, other medication use, and the reporter's contact information. A single reporting form should be used to submit reports via various methods.
Regulatory affairs is the interface between pharmaceutical companies and government regulatory agencies. It involves activities related to drug research, development, manufacturing, registration, evaluation, authorization, distribution, pricing, advertising, and post-marketing surveillance. Regulatory affairs professionals ensure compliance with relevant regulations and guidelines from agencies like the FDA, EMA, and other national authorities. They prepare and submit regulatory dossiers containing technical data to obtain approval for new drugs or changes to approved drugs. Common elements of dossiers include quality summaries, non-clinical and clinical study reports, chemistry and manufacturing information, and regional prescribing information.
Schedule Y outlines the regulatory requirements for conducting clinical trials in India. It provides guidelines on applying for trial approval, sponsor and investigator responsibilities, informed consent, trial phases and types of studies. The document discusses amendments made to Schedule Y over time to align it more closely with ICH-GCP guidelines. It also describes the 11 appendices that provide details on topics like pre-clinical data submission, animal studies, ethics committee composition, serious adverse event reporting, and stability testing. The goal of Schedule Y is to improve clinical trial quality and ensure data standards are globally accepted.
Regulatory affairs ensures that pharmaceutical products meet legislative requirements by studying scientific and legal documents, gathering and organizing submission documents, and collating information for regulatory authorities. The Common Technical Document format is used for new drug applications and provides a harmonized structure for applications submitted to agencies like the US FDA and EMA. The US FDA filing process involves applications like Investigational New Drug Applications, New Drug Applications, and Abbreviated New Drug Applications for generic drugs. Regulatory authorities differ between fully regulated markets and semi-regulated markets.
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.
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
The document provides information on the regulatory approval process for drugs. It discusses the various stages of approval including investigational new drug applications (IND), new drug applications (NDA), and abbreviated new drug applications (ANDA).
The stages include pre-clinical testing, clinical trials through multiple phases, and regulatory review and approval. An IND must be approved by the FDA before clinical trials in humans can begin. If clinical trials are successful, manufacturers can file an NDA to request approval to market the drug. For generic drugs, an ANDA can be filed to demonstrate bioequivalence to an existing approved drug, without needing to re-conduct clinical trials. The approval process is complex and lengthy, usually taking 10-
FIXED DOSE COMBINATIONS REGULATIONS IN INDIA AND A CASE STUDY ON THE TOP SELL...JAYA PRAKASH VELUCHURI
This document summarizes a review of clinical trial evidence for metformin fixed-dose combinations (FDCs) used to treat type 2 diabetes in India. The review found:
- Only 25 relevant clinical trials were identified, with most comparing metformin FDCs to monotherapy rather than the individual components.
- None of the trials met all of the WHO's criteria for size, duration, design, and assessing adverse reactions.
- Only 3 trials were conducted in India, with one including just 101 patients over 2 months.
- Despite a lack of robust evidence, over 50 metformin FDCs have been approved in India. The document calls for Indian regulators to make their review and approval evidence public, and to strengthen clinical trial requirements
This document outlines requirements and guidelines for importing or manufacturing new drugs in India according to Drugs and Cosmetics Rules. It defines key terms like new drug, clinical trial, adverse events and reactions. It describes application procedures for new drug development and permissions under Form 44. Responsibilities of sponsors, investigators and ethics committees are provided. Important considerations for human clinical pharmacology, periodic safety update reports, label and carton drafting, and bioequivalence studies are highlighted.
Schedule Y provides requirements and guidelines for permission to import and manufacture new drugs for sale or to undertake clinical trials in India. It outlines the application process and requirements, including pre-clinical data that must be submitted. It describes the responsibilities of sponsors, investigators, and ethics committees for clinical trials. Clinical trials must progress through Phases I-IV and special population studies may be required. Post-marketing surveillance is also addressed. The purpose is to regulate new drugs and ensure clinical research is properly conducted according to good clinical practice standards.
This document summarizes trends shaping workers' compensation medication policies in 2014. It discusses the influence of various factors, including political influences from the Affordable Care Act and state elections; clinical influences like an aging population and the opioid epidemic; and product influences as new medications enter the market. It also outlines debates around issues like physician dispensing, compounded medications, medical marijuana, and opioid monitoring programs.
Epilepsy Drugs Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Op...IMARC Group
The global epilepsy drugs market size reached US$ 2.3 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 4.4 Billion by 2032, exhibiting a growth rate (CAGR) of 7.16% during 2024-2032.
More Info:- https://www.imarcgroup.com/epilepsy-drugs-market
The WHO Model Lists of Essential Medicines are updated every two years by the Expert Committee on Selection and Use of Essential Medicines.
The first Essential Medicines List was published in 1977, and the first Essential Medicines List for Children was published in 2007.
The current versions, updated in September 2021, are the 22nd Essential Medicines List (EML) and the 8th Essential Medicines List for Children (EMLc).
This document provides an overview of drug utilization research (DUR). It defines DUR as the marketing, distribution, prescription, and use of drugs in a society and its resulting medical, social and economic consequences. The document outlines the history, levels, aspects, study designs, and guidelines for DUR based on WHO standards. It describes quantitative and qualitative DUR approaches and explains indicators like the Anatomical Therapeutic Chemical classification system and Defined Daily Dose concept for standardized DUR analysis. The goal of DUR is to promote rational and appropriate drug use.
This document provides an overview of the scope of pharmacology. It discusses the history and evolution of pharmacology from materia medica and early pharmacy to its modern academic, industrial and research applications. Key areas of pharmacology discussed include drug development process, clinical pharmacology, special domains like pharmacovigilance, pharmacoeconomics and emerging areas like pharmacogenomics. The document outlines the past, present and future scope of pharmacology and how it aims to advance human health through rational and safe use of medicines.
The document discusses various stages of drug discovery and development. It begins with an introduction to traditional methods of drug discovery and advances in understanding disease at the molecular level. It then covers key stages like drug discovery, preclinical studies, clinical trials, and regulatory approvals required by agencies like the FDA and India's CDSCO. Different types of applications submitted during development and regulatory processes are explained, including IND, NDA, ANDA, SNDA, and supplements for post-approval changes. Challenges and methods in each stage are also summarized.
The document summarizes several regulatory agencies that regulate pharmaceutical products around the world. It discusses the roles and functions of the CDSCO in India, FDA in the United States, TGA in Australia, Health Canada, and MHRA in the UK. For each agency, it provides information on their goals, activities related to drug approval and regulation, and key application forms.
This document summarizes presentations from a clinical track on decreasing opioid risks and exploring non-opioid options for pain management. It discusses the FDA and VA's responses to the opioid epidemic through decreasing opioid prescribing and exploring alternatives. Robert Bianchi discusses the FDA's guidance for developing abuse-deterrent opioids and evaluating claims about abuse-deterrence through laboratory studies. Michael Saenger discusses applying a biopsychosocial model to chronic pain diagnosis and treatment rather than a biomedical model, using a coaching approach to self-management, and applying neuroplasticity principles. The document emphasizes considering the whole person and moving away from a focus on prescription opioids for chronic pain.
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
This document provides a summary of common regulatory affairs job interview questions and answers. It begins with defining regulatory affairs and its goals of protecting human health, ensuring drug safety and efficacy, and ensuring accurate product information. It then discusses the roles of regulatory affairs professionals in interacting with regulatory agencies, preparing submissions, and ensuring compliance. The rest of the document provides answers to common interview questions about regulatory submissions, guidelines, authorities, and key concepts and legislation related to drug approval.
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
The document summarizes a presentation on abuse-deterrent formulations of opioids given by Douglas Throckmorton of the FDA and Richard Dart. It discusses the FDA's efforts to encourage development of abuse-deterrent opioids through guidance and regulatory decisions. While progress has been made, challenges remain in developing, testing, and assessing the real-world impact of abuse-deterrent technologies. The FDA aims to improve treatment of pain while reducing risks of prescription drug abuse and overdose through multiple strategies.
This document provides an overview of the non-clinical development process and global submission of Investigational New Drug Applications (IND), New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA). It discusses the purpose and requirements for IND, NDA, and ANDA submissions to regulatory agencies globally. Key points include the format and content of IND, NDA, and ANDA submissions, as well as criteria for IND applications and the review process by regulatory agencies. The goal is to obtain approval to conduct clinical trials for an investigational drug or market a new pharmaceutical product.
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.
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PAIN MANAGEMENT- NEW DISCOVERIES AND TREATMENT OPTIONS IN ABUSE DETERRENT ERA
1. 1 | P a g e
THERAPEUTIC CLASS OVERVIEW
PAIN MANAGEMENT- NEW DISCOVERIES
AND TREATMENT OPTIONS
IN ABUSE DETERRENT ERA
• Opioids - Novel Abuse deterrent Formulation Technologies &
Pipeline drugs
• Emerging Novel Technologies, Mechanisms and late stage
pipeline drugs in the Management of Pain
Rescheduling of Hydrocodone combinations from Class III to Class II, clear-cut regulatory
guideline for Abuse Deterrent drug formulation NDA & ANDA (solid oral) filing and CDC
guideline for Prescribing Opioids for Chronic Pain (2016) are definite steps taken by FDA in
last two years for creating “Abuse Deterrent Era” in a short span to stop opioid abuse and
reversing opioid epidemic in USA. There were around 18,893deaths involving prescription
of opioids in the United States in 2014 which was up 16% from 2013 as per NCHS (National
Center for Health Statistics).
Around +6 plus extended release abuse deterrent formulations with Abuse deterrent (AD)
labels are approved in last two years (Xtampza ER, MorphaBond ER, Hysingla ER, Embeda
ER, Targiniq ER, Oxaydo) and are expected to provide improvements over existing
formulations for abuse deterrent purpose. But they have some limitation for restricting
abuse mainly through oral intake- swallowing a number of intact tablets or capsules.
Despite, Extended release (ER) Abuse Deterrent Formulations partly control Opioids abuse
(through nasal or injection routes), ER opioids has high potential of abuse, its AD
formulation add significant value to create “Abuse Deterrent Era” in the coming time.
Around 20 plus Abuse Deterrent Formulations of opioids are in the pipeline and most of
them are ER formulations which use different AD tech platform to make its ADF. Amongst
these pipeline ADF drugs, 6 are of Hydrocodone, 8 are of Morphine and 6 are of Oxycodone
based ADF formulations.
New NCEs targeting Opioids receptor are in pipeline which reduces Opioids abuse by its
MoA (slow rate of entry in Brain) and may have potential to deal with reducing opioid abuse
through restricting oral intake in coming years.
US Opioids market is of $8b in size and of which extended release formulations contribute
50%. ADF ER formulations and its generic versions & New NCEs targeting Opioid receptor
will drive the growth of this market in US and Europe in coming years.
Late stage NCE pipeline drugs (Cebranopadol, Mirogabalin, NKT-181, AVP-923,…) and
Novel technologies targeting formulation change in old generic drugs (ORB-201, OX-51,
ARX-04,CL-108, once daily Pregabalin..) for pain management has potential to reduce
2. 2 | P a g e
opioid use in future to treat pain. While TRKA receptor antagonist, NAV1.7 sodium channel
modulator inhibitor and angiotension II antagonist are few new MoA which has promising
drug in clinical development for moderate to severe pain management.
In this report, we have discussed a number of novel delivery technologies employed in
formulating abuse deterrent product, technologies employed in enhancing patient
compliances, emerging novel mechanisms and late stage pipeline drugs in the management
of pain.
Table of Contents
1. Executive Summary
a. ER formulation of Opioids- An initial target for pipeline Abuse deterrent
drugs & a high priority by Regulators?
b. Late stage pipeline drugs and new MoA – which has potential to reduce
Opioid use in moderate pain?
c. New FDA guidelines for Oral solid abuse deterrent generic formulations - A
kick start of generic cycle for ADF formulations?
d. Key pipeline ER abuse deterrent drugs, its ROA, tech platform etc
e. Possible implications of rescheduling Hydrocodone from CIII to CII on
Opioids market & ADF development.
2. Management of Pain
• Introduction
• Classification of Pain (Type and Intensity)
• Treatment of chronic pain – current approach
• Market Size of pain and current therapeutic options (acute, chronic pain and
neuropathic pain)
• Unmet medical need and market opportunities in overall Pain management
• Overview of Marketed drugs for moderate to severe pain and neuropathic
pain
• Limitations of non-opioids drugs and overview of marketed drugs
• Non-steroidal Anti-inflammatory Drugs (NSAID) – Mechanism of action
• Necessity for non-opiate treatment –Drug abuse deterrent and tolerance
• Opioid Abuse deterrent Epidemic- A Whistle Blower for FDA to take
Stringent Action and start of abuse deterrent Era
• ER opioids vs. IR opioids- Abuse deterrent potential
3. FDA Schedule for controlled substances and advantage of Schedule III over II
• Hydrocodone rescheduling to Class II –
o Prescription trend post rescheduling
o Advantage to other Opiates & advantage to ER ADF opioids to
grow due to rescheduling
3. 3 | P a g e
4. FDA Perspective on Abuse deterrent formulations (Opioids)
• FDA perspective on Abuse deterrent Opioids- Observations from early
experience with Abuse deterrent formulation development.
• FDA view of the Evolution of the Abuse deterrent Opioid market
• Tools FDA Intends to use to move the market toward its goal
• ADF Labeling – Importance and advantage for reimbursement, REMS
need
• Our view on FDA guidelines for Abuse deterrent Formulation
developments
• Our view on FDA guidelines for Generic Abuse deterrent Formulation
developments
5. Approved Abuse deterrent Formulations by FDA - Development , label claim,
Technology and current prescription trend
• Common Manufacturing approach for making ADF formulation
• Abuse deterrent drugs approval from FDA in 2014- its Technology
platform and current prescription trend in US
• Abuse deterrent approval from FDA in 2015- its Technology platform and
current prescription trend in US
• Recently approved ER Formulation of Patent expired molecules for pain
management
• Nucynta ER
• Gralise
• Horizant
6. Abuse Deterrent Technology Platforms employed in marketed drugs and
pipeline
a. AVERSION
b. IMPEDE
c. NEXAFED
d. LIMITX
e. DETERx
f. PODRAS
g. IntelliPaste
h. nPODDDS
i. INTAC
j. ORADUR
k. Implantable pump for intrathecal delivery
l. OPTIGEL Lock
m. Small molecule delivery
n. Bio-MD-prodrugs platform
o. Ligand activated Therapy (LAT)
p. NOBUSE
q. EGALET
r. ABUSOLVE
4. 4 | P a g e
s. Inspirion delivery Technologies
t. Intellitab Technology
u. Trigger lock platform –Micropump
v. Proprietary / OraGuard Technology
w. Pain Therapeutics
x. Fenrock
y. Smart Patch PNS system
z. ALO-02/Troxyca ER
aa. BeadTek and INTELLITAB technology
bb. Acuform Technology
cc. OROS Technology
dd. Resistec Technology
ee. SENTRYBOND Technology
7. Pipeline analysis of Novel Technologies and new mechanisms in Pain
management
Novel Technologies-
a. Multi-day formulation of Tramadol
b. Bio-MD Platform
c. Orexo- Sublingual technology
d. Fentanyl based therapy formulation modification (micro and nano tab)
e. Acorda Therapeutics
f. Bilayered oral formulation- Charleston lab
g. ZilrettaTM
h. Steroidal intraarticular injection
i. Intrathecal drug delivery system
j. Oromucosal delivery
New mechanisms in Pain management
a. Angiotension II antagonist
b. Anti-NGF
c. Ligand Activate Therapy
d. Nav1. 7 inhibitor
e. GPCR –Dimer Screen Technology
f. CB agonist
g. Kappa Receptor agonists
h. TrkA receptor antagonist
i. MAP kinase inhibitor
j. Opioid alternatives (dexmedetomidine)
k. Peptide Therapeutics (conopeptide)
l. TRPV1 antagonist
m. Gene therapy
n. Others
5. 5 | P a g e
8. Late stage pipeline developments in neuropathic pain
a. Cebranopadol (oral, once daily, Grunenthal/ Depomed, PhIII, chronic pain)-
A potential threat to abuse deterrent formulations
b. Mirogabalin- Key MOA diff vs. Lyrica, Pros & Cons analysis based on
reported PhII data
c. CL-108
d. Hydromorphone
e. Convergence/ biogen Idec- CNV-2197944
f. Convergence/ biogen Idec- CNV-1014802
g. Sativex
h. Once daily pregabalin
i. Topical clonidine gel
j. Topical ketamine and amitraline
k. Amorsa therapeutics
l. Pregabalin CR
m. Eladur
n. GRC-17536
o. DWP05195
p. AVP-123
q. Algiax Pharmaceuticals
Appendix – I FDA Guidelines for the development of abuse Deterrent Formulations
• Types of Abuse deterrent formulation as per current guidance
• Pre market studies
• Post market studies
• Labeling Recommendations
Appendix- II General Principles for Evaluating the Abuse deterrent Generic Solid Oral
Opioid Drug Products
Need for regulatory filing and other key requirements
Route of Abuse deterrent
Comparative in Vitro Studies
Other Consideration
Data Analysis
Additional Studies
8. 8 | P a g e
Tables:
Table-1(A): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-1(B): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-1(C): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-1(D): Key pipeline ER Abuse Deterrent Drugs, its ROA, techplatform
Table-2: Non-Injectable Opioid Pain TRx+share-US
Table-3: Classification Based on Intensity of Pain 2013-2014
Table-4: Marketed Fentanyl Dosage Forms (Us): Transdermal Patches, Buccal And
Sublingual Tablets And Films For Pain Relief
Table-5: Commonly Used Opioids for Pain Management
Table-6: Marketed Drugs for Neuropathic Pain
Table-7: Drug Enforcement Authority (DEA) Controlled Substances Schedule Criteria
Table-8: Summary of Controlled Substances Act requirements
Table-9: Overview of pivotal studies conducted in the ALO-02 development program
Table-10: Benefits of Sublingual Microtablets vs. IV morphine Patient Controlled Analgesia
Table-11: Marketed formulation of Oromucosal product
Table-12: Microgabalin –WW ongoing key clinical trials
Charts:
Chart -1: Classification of Pain
Chart-2: Pain is multi-factorial
Chart-3: Pain Relief ladder-WHO
Chart-4: Neuropathic Pain market size and projection through 2020
Chart-5: Medicine spending in 2020 US$ by geography, product type and disease area
Chart-6: Specialty Medicines and Leading therapy areas in 2020
Chart-7: Number of Death from Prescription drugs
Chart-8: Number of Death from Heroin
Chart-9: Hydrocodone prescription volume has noticeably declined since up-scheduling
Chart-10: Total opioid market TRx and sales growth
Chart-11: Recent long acting opioids TRx launches
Chart-12: NUCYNTA ER prescription trend-us post launch in June 2015
Chart-13: Abuse Deterrent pipeline in development-Acura pharma
9. 9 | P a g e
Chart-14: DETERx Multiparticulate system
Chart-15: Design element of DETERx as used in Xtampza
Chart-16: Pipeline of Collegium Pharma
Chart-17: Pipeline of Intellipharmaceuticals
Chart-18: Abuse Deterrent Technology platform of Elite Pharmaceuticals
Chart-18(a): Abuse Deterrent Technology platform- One Bead System
Chart-18 (b): Abuse Deterrent Technology platform- Two Bead System
Chart-19: Guardian Technology combines abuse deterrent- features with a precision
zero-order profile
Chart-20: Egalet product pipeline using GuardianTM
Technology
Chart-21: Egalet’s guardian technology as used in ARYMO and Egalet-002
Chart-22: OraguardTM
Manufacturing process used for Vantrela ER
Chart-23: Diagram of the cross-section of an ALO-02 pellet
Chart-24: Zohydro ER’s BeadTek technology-PEO Gels in liquids
Chart-25: Exalgo’s OROS Delivery technology- Deigned for ER not ADF
Chart-26: Stratum Tech platform- Orbis Bioscience
Chart-27: Tramadol in Vitro Pharmacokinetic
Chart-28: PF614: Prodrug of Oxycodone (ER Oxycodone)
Chart-29: Pipeline of Enysce Bioscince
Chart-30: ZilrettaTM
cilical phase study for pain
Chart-31: Biodelivery science International BEMA technology
Chart-32: Product in pipeline utilizing BEMA technology
Chart-33: Advance in Orodispersible film for drug delivery
Chart-34: Cara therapeutics drug development
Chart-35: Cebranopadol overview
Chart-36: Cebranopadol MOA- Uniquely differentiate
Chart-37: Cebranopadol phase II clinical trial summary
Chart-37 (a): Cebranopadol phase II clinical trial summary
Chart-37 (b): Cebranopadol phase II clinical trial summary
Chart-38: Cebranopadol reduced Abuse Deterrent potential
Chart-39: Daiichi sankyo (Efficacy result of mirogabalin vs. Lyrica/Pregabalin)
Chart-40: A flow chart depicting a tier-based approach to evaluating the extractability of
Opioid from an intact product for ingestion