CTD ~ Common Technical Document
•
2 likes•990 views
The document describes the five modules of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format for ASEAN countries. Module 1 contains regional administrative information. Module 2 provides an overall summary of Modules 3, 4, and 5, including quality, non-clinical, and clinical overviews. Module 3 includes chemistry, manufacturing, and quality control documents. Module 4 contains non-clinical safety data. Module 5 provides clinical study reports, though generics only need to include bioequivalence studies. The CTD format is required for both new drug and generic applications in ASEAN countries.
Report
Share
Report
Share
Download to read offline
Recommended
Dossier Preparation/ CTD (Common Technical Document)
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Electronic Common Technical Document (eCTD)
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Regulatory dossier preparation and submission as per CTD format
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
Pharmaceutical Dossier submission
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines dossiers as collections of documents providing detailed information about a subject. Registration dossiers contain all administrative, quality, nonclinical and clinical data required for approval of a pharmaceutical product in a given country. Common dossier formats used in the industry include CTD, ACTD and eCTD formats, which organize information into modules. Proper planning, compilation and review are important for effective dossier management and regulatory submission.
eCTD Submissions
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
CTD AND ECTD
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for registration dossier submissions. It provides background on the International Conference on Harmonization (ICH) and its role in harmonizing technical requirements for drug registration. The key points covered are:
1) The CTD format was created by ICH to provide a standardized common format for drug registration submissions across regions/countries.
2) The eCTD specification was later developed as the electronic equivalent of CTD to streamline the submission and review process.
3) Benefits of eCTD include improved handling of submissions, better information management, and increased efficiency of the evaluation and review process.
505 (b) (2)
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
Pharma regulatory affairs
The document provides information about regulatory affairs and the registration process for pharmaceutical products. It defines key terms like dossier, DMF, CTD/eCTD, and regulatory filing types. It describes the modules of a common technical document for a product registration, including the administrative, summary, quality, non-clinical and clinical sections. Electronic submission using eCTD format is also discussed. Country-specific regulatory agency websites are listed.
Recommended
Dossier Preparation/ CTD (Common Technical Document)
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Electronic Common Technical Document (eCTD)
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Regulatory dossier preparation and submission as per CTD format
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
Pharmaceutical Dossier submission
This document discusses dossier preparation and submission for regulatory approval of pharmaceutical products. It defines dossiers as collections of documents providing detailed information about a subject. Registration dossiers contain all administrative, quality, nonclinical and clinical data required for approval of a pharmaceutical product in a given country. Common dossier formats used in the industry include CTD, ACTD and eCTD formats, which organize information into modules. Proper planning, compilation and review are important for effective dossier management and regulatory submission.
eCTD Submissions
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
CTD AND ECTD
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for registration dossier submissions. It provides background on the International Conference on Harmonization (ICH) and its role in harmonizing technical requirements for drug registration. The key points covered are:
1) The CTD format was created by ICH to provide a standardized common format for drug registration submissions across regions/countries.
2) The eCTD specification was later developed as the electronic equivalent of CTD to streamline the submission and review process.
3) Benefits of eCTD include improved handling of submissions, better information management, and increased efficiency of the evaluation and review process.
505 (b) (2)
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
Pharma regulatory affairs
The document provides information about regulatory affairs and the registration process for pharmaceutical products. It defines key terms like dossier, DMF, CTD/eCTD, and regulatory filing types. It describes the modules of a common technical document for a product registration, including the administrative, summary, quality, non-clinical and clinical sections. Electronic submission using eCTD format is also discussed. Country-specific regulatory agency websites are listed.
Ctd and e ctd
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats used for submitting registration documents to international regulatory agencies. The CTD format organizes documents into 5 modules: Module 1 contains administrative information specific to each region; Module 2 contains summaries of quality, non-clinical, and clinical information; Module 3 contains quality/manufacturing data; Module 4 contains non-clinical study reports; and Module 5 contains clinical study reports. The eCTD format is the electronic version of CTD, with documents in PDF format linked together via an XML backbone for easier navigation and review compared to the paper CTD format.
CTD and E-CTD Regulatory Affairs
Detail information about CTD & E-CTD
It's history and evolution, Objectives, Submission process, ICH role, Modules included, CTD Triangle,.....etc
CTD (common technical document)
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
Common Technical Document
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It describes the evolution and adoption of the CTD internationally and in India. The CTD aims to streamline the drug approval process and facilitate simultaneous reviews by different regulators. It is organized into five modules covering administrative information, summaries, quality, nonclinical data, and clinical data. Widespread use of the CTD format has allowed for greater harmonization and efficiency in global pharmaceutical development and regulation.
Hatch waxman act
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
DMF CEP
The document provides an overview of Drug Master Files (DMFs) and Certificates of Suitability (CEPs) for drug substances. It describes that a DMF is a confidential submission to regulatory agencies containing manufacturing and quality control information about a substance or component. It discusses the different types of DMFs, how they are submitted and reviewed, annual reporting requirements, and retirement. It also describes that a CEP is issued by EDQM and demonstrates that a substance's purity is controlled according to European Pharmacopoeia monographs, easing approval in Europe.
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Dossier format and filing.pptx
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
CTD Guidelines Overview
The document provides an overview of the Common Technical Document (CTD) format for organizing technical requirements for a generic drug product application to be submitted to regulatory authorities. It describes the CTD format, which includes Modules 1 through 5. Module 2 includes quality, non-clinical and clinical summaries. Module 3 contains information related to the drug substance and product quality. Module 5 contains clinical study reports, which for generic products would primarily include bioequivalence studies comparing the generic to an approved drug.
eCTD
This document discusses electronic submission of drug applications using the electronic common technical document (eCTD) format. It provides an overview of eCTD, including its module structure and requirements. The key points covered are:
- Regulatory agencies now prefer eCTD format over paper submissions for drug applications due to benefits like reduced storage needs, increased accountability and easier review.
- eCTD format organizes information into modules covering administrative data, summaries, quality documentation, non-clinical and clinical studies reports.
- The document provides guidance on creating an eCTD submission, including use of the required eCTD software and structure, and submitting a test filing to address any issues before final submission.
Comparative study of drug approval system in usa, europe & japan
this ppt is about the regulatory process of drug approval in different countries like USA, Europe, and Japan by the authority of FDA, EMA & PMDA.
Content and format of dossier filling in india
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
Introduction to ctd (common technical document)
The document provides an overview of the Common Technical Document (CTD), which was created through collaboration between the European Medicines Agency, US Food and Drug Administration, and Japan's Ministry of Health to standardize the submission format for new drug applications. The CTD consists of 5 modules, with Module 1 containing region-specific information and Modules 2 through 5 containing common quality, non-clinical, and clinical summaries and reports. The goals of the CTD were to create a more consistent application format that streamlines review, facilitates information exchange, and reduces the resources needed for global drug registration.
Registration requirments for cis countries
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
Prior Approval Supplements (PAS)
This presentation explains in brief the process, types, requirements, and conditions where PAS is needed to submit by drug manufacturers.
US and EU Submission – Comparative
The document compares the regulatory processes for drug product submissions in the US and EU. In the US, applications are submitted to the FDA's Center for Drug Evaluation and Research and can be New Drug Applications or Abbreviated New Drug Applications. In the EU, applications are submitted through national regulatory authorities or through the centralized European Medicines Agency process. The key differences between the US and EU processes include differences in application types, approval timelines, post-approval change requirements, manufacturing standards, quality testing standards, and facility inspection processes.
Cmc and post regulatory
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
US FDA post approval changes
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
ACTD Guidelines Overview
The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.
Common Technical Document : A Regulatory Document
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
Common technical document
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting marketing authorization applications for pharmaceuticals to regulatory authorities. The CTD format was developed by the International Conference on Harmonization to streamline the application process across the US, EU, and Japan. It consists of 5 modules covering administrative information, quality, safety, efficacy, and technical documents. The goal of the CTD is to make application reviews more efficient by providing a consistent organization of data across regions.
More Related Content
What's hot
Ctd and e ctd
The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats used for submitting registration documents to international regulatory agencies. The CTD format organizes documents into 5 modules: Module 1 contains administrative information specific to each region; Module 2 contains summaries of quality, non-clinical, and clinical information; Module 3 contains quality/manufacturing data; Module 4 contains non-clinical study reports; and Module 5 contains clinical study reports. The eCTD format is the electronic version of CTD, with documents in PDF format linked together via an XML backbone for easier navigation and review compared to the paper CTD format.
CTD and E-CTD Regulatory Affairs
Detail information about CTD & E-CTD
It's history and evolution, Objectives, Submission process, ICH role, Modules included, CTD Triangle,.....etc
CTD (common technical document)
The document discusses the Common Technical Document (CTD) format for drug applications. It was developed through the International Conference on Harmonization to standardize application formats across regions like Europe, Japan, and the United States. The CTD format organizes drug applications into five modules covering administrative information, overview/summaries, quality/manufacturing, safety/toxicology, and efficacy/clinical data. Adopting a common CTD format provides benefits like reducing redundant testing and facilitating information sharing between regulatory agencies.
Common Technical Document
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting documentation to regulatory authorities for approval of pharmaceutical products. It describes the evolution and adoption of the CTD internationally and in India. The CTD aims to streamline the drug approval process and facilitate simultaneous reviews by different regulators. It is organized into five modules covering administrative information, summaries, quality, nonclinical data, and clinical data. Widespread use of the CTD format has allowed for greater harmonization and efficiency in global pharmaceutical development and regulation.
Hatch waxman act
The Hatch-Waxman Act established regulations for generic drugs in the US to facilitate generic competition. It created an Abbreviated New Drug Application process for generics to gain approval more quickly by showing bioequivalence to branded drugs. The first generic to challenge a patent via Paragraph IV certification gains 180 days of marketing exclusivity. The Act also allows patent term extensions for branded drugs to compensate for regulatory approval times. While increasing generic competition, it provides benefits to branded manufacturers such as data and market exclusivities as well as patent dispute resolutions.
DMF CEP
The document provides an overview of Drug Master Files (DMFs) and Certificates of Suitability (CEPs) for drug substances. It describes that a DMF is a confidential submission to regulatory agencies containing manufacturing and quality control information about a substance or component. It discusses the different types of DMFs, how they are submitted and reviewed, annual reporting requirements, and retirement. It also describes that a CEP is issued by EDQM and demonstrates that a substance's purity is controlled according to European Pharmacopoeia monographs, easing approval in Europe.
cmc [ chemistry manufacturing control ]
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Dossier format and filing.pptx
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
CTD Guidelines Overview
The document provides an overview of the Common Technical Document (CTD) format for organizing technical requirements for a generic drug product application to be submitted to regulatory authorities. It describes the CTD format, which includes Modules 1 through 5. Module 2 includes quality, non-clinical and clinical summaries. Module 3 contains information related to the drug substance and product quality. Module 5 contains clinical study reports, which for generic products would primarily include bioequivalence studies comparing the generic to an approved drug.
eCTD
This document discusses electronic submission of drug applications using the electronic common technical document (eCTD) format. It provides an overview of eCTD, including its module structure and requirements. The key points covered are:
- Regulatory agencies now prefer eCTD format over paper submissions for drug applications due to benefits like reduced storage needs, increased accountability and easier review.
- eCTD format organizes information into modules covering administrative data, summaries, quality documentation, non-clinical and clinical studies reports.
- The document provides guidance on creating an eCTD submission, including use of the required eCTD software and structure, and submitting a test filing to address any issues before final submission.
Comparative study of drug approval system in usa, europe & japan
this ppt is about the regulatory process of drug approval in different countries like USA, Europe, and Japan by the authority of FDA, EMA & PMDA.
Content and format of dossier filling in india
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
Introduction to ctd (common technical document)
The document provides an overview of the Common Technical Document (CTD), which was created through collaboration between the European Medicines Agency, US Food and Drug Administration, and Japan's Ministry of Health to standardize the submission format for new drug applications. The CTD consists of 5 modules, with Module 1 containing region-specific information and Modules 2 through 5 containing common quality, non-clinical, and clinical summaries and reports. The goals of the CTD were to create a more consistent application format that streamlines review, facilitates information exchange, and reduces the resources needed for global drug registration.
Registration requirments for cis countries
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
Prior Approval Supplements (PAS)
This presentation explains in brief the process, types, requirements, and conditions where PAS is needed to submit by drug manufacturers.
US and EU Submission – Comparative
The document compares the regulatory processes for drug product submissions in the US and EU. In the US, applications are submitted to the FDA's Center for Drug Evaluation and Research and can be New Drug Applications or Abbreviated New Drug Applications. In the EU, applications are submitted through national regulatory authorities or through the centralized European Medicines Agency process. The key differences between the US and EU processes include differences in application types, approval timelines, post-approval change requirements, manufacturing standards, quality testing standards, and facility inspection processes.
Cmc and post regulatory
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
US FDA post approval changes
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
ACTD Guidelines Overview
The document provides an overview of the requirements and guidelines for generic drug dossiers using the ASEAN Common Technical Document (ACTD) format. It describes the organization of the ACTD, which contains four parts covering administrative data, quality documents, nonclinical documents, and clinical documents. Part I includes the table of contents, administrative information, and product information. Part II focuses on quality documents for the drug substance and product. Parts III and IV are generally not applicable for generic drugs. The document also lists the types of documents required to complete each part of the ACTD for a generic drug application.
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.
What's hot (20)
Comparative study of drug approval system in usa, europe & japan
Comparative study of drug approval system in usa, europe & japan
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Similar to CTD ~ Common Technical Document
Common Technical Document : A Regulatory Document
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
Common technical document
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting marketing authorization applications for pharmaceuticals to regulatory authorities. The CTD format was developed by the International Conference on Harmonization to streamline the application process across the US, EU, and Japan. It consists of 5 modules covering administrative information, quality, safety, efficacy, and technical documents. The goal of the CTD is to make application reviews more efficient by providing a consistent organization of data across regions.
CTD and eCTD Format
CTD and eCTD is a format set by ICH which was accepted by the regulatory agencies of US, EUROPE, and JAPAN.
Ctd ppt
The document discusses the Common Technical Document (CTD), which provides a standardized format for new drug applications across Europe, Japan, and the US. The CTD is organized into 5 modules: Module 1 contains region-specific information; Modules 2-5 are common across regions. Module 2 provides overviews and summaries of quality, non-clinical, and clinical data in Modules 3-5. The CTD format aims to streamline drug approvals across major markets.
Common Technical Document CTD,M pharm@ 1st year
The document discusses the Common Technical Document (CTD), which is a standardized format for submitting documentation to regulatory agencies in Europe, Japan, and the United States. It describes the CTD's five modules, which contain administrative information, summaries, quality data, nonclinical study reports, and clinical study reports. The CTD format was developed by international drug regulatory bodies to harmonize the technical requirements for marketing new pharmaceuticals. It has been adopted as the standard application dossier across major global drug markets.
Regulatory Affairs role in Pharmaceutical Industry
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
NDA.pptx
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
NDA.pptx
The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
CTD and ECTD by Akshay Trivedi
The document discusses the Common Technical Document (CTD) format, which is used for new drug applications submitted to regulatory agencies in Europe, Japan, and the United States. The CTD format aims to increase harmonization across regions. It is organized into five modules covering administrative information, summaries, quality information, nonclinical study reports, and clinical study reports. An electronic version of the CTD (eCTD) uses XML formatting to improve the submission and review process. The eCTD allows for increased accuracy, reduced costs and time to market, and easier navigation compared to the paper CTD format.
CTD and eCTD.pptx
The document discusses CTD (Common Technical Document) and eCTD (electronic Common Technical Document). CTD is an internationally agreed format for organizing technical documents for new drug applications. It was created to harmonize application formats between regions like the US, EU, and Japan. eCTD builds upon CTD by allowing electronic submission and review of applications using an XML structure for easy transfer and organization of information. Both CTD and eCTD aim to streamline the drug approval process globally by creating standardized common formats for application dossiers.
Regulatory affairs-Introduction to CTD
Regulatory affairs is the bridge between pharmaceutical companies and government regulatory agencies. It involves all activities related to drugs, including research, clinical trials, manufacturing, registration, distribution, pricing, advertising, and post-marketing surveillance. Regulatory dossiers contain all required technical data and documentation needed to obtain approval to market a drug in a given country or region. Common formats include the Common Technical Document for Europe, US, and other markets and Form 44 for India. Compliance with good practices and local regulations is essential for regulatory approval.
Common techanical document(ctd)
The document discusses the Common Technical Document (CTD), which provides a standardized format for submitting information to regulatory agencies in the US, Europe, and Japan. The CTD was created through collaboration between these agencies to streamline the drug approval process. It outlines a consistent organization of administrative information, summaries, quality/manufacturing data, safety/efficacy testing results, and other documents required for review. Later, the CTD transitioned to an electronic format (eCTD) to facilitate electronic submission and review of applications.
Overcoming the stress of non-prescription medicine application screening - Co...
This presentation will describe how the TGA undertakes the screening process and will discuss the mandatory requirements for applications, including specific examples of problems commonly encountered.
CTD-eCTD Regulatory .pptx
The document discusses Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD), which provide a standardized format for new drug applications. CTD/eCTD applications are organized into five modules covering administrative information, summaries, quality, non-clinical studies, and clinical studies. eCTD builds upon CTD by making submissions electronic rather than paper-based, allowing for increased document granularity, transparency, navigation and review efficiency compared to traditional CTD formats. The standardized CTD/eCTD format is recognized by regulatory agencies in Europe, Japan, United States and aims to streamline the drug approval process.
NEW DRUG APPLICATION ( NDA)
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
The document discusses the process for product registration and drug approval in the United States. All new drug products must complete a registration process with the FDA to ensure safety and efficacy. This involves submitting a New Drug Application (NDA) containing clinical and manufacturing data and information. The NDA goes through a review process by FDA teams with expertise in technical areas. The review determines if the drug is approved for marketing in the United States.
Drug Regulatory affairs
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.
Regulatory requirement on dossier of medicinal products
The document provides an overview of the Common Technical Document (CTD) format for regulatory drug dossiers. The CTD format organizes a drug application into five modules, with Modules 2-5 constituting the core CTD. Module 2 contains summaries of quality, nonclinical, and clinical information from Modules 3-5. It outlines the content and format requirements for key summaries in Module 2, including the Quality Overall Summary, Nonclinical Overview, Clinical Overview, and other summaries. The CTD format aims to create a well-organized, consistent structure across regions to facilitate regulatory review of drug applications.
Introduction to Pharma regulatory affairs
Regulatory affairs is a profession that developed to oversee the regulation of products like pharmaceuticals, medical devices, and cosmetics by government agencies to ensure public health and safety. Regulatory affairs departments act as the interface between companies in regulated industries and regulatory agencies around the world. They track changing legislation, submit registration documents to agencies, and provide strategic and technical advice to other departments like R&D, manufacturing, and quality assurance.
Registration of Indian Drug Product in Overseas Market.pptx
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
Similar to CTD ~ Common Technical Document (20)
Regulatory Affairs role in Pharmaceutical Industry
Regulatory Affairs role in Pharmaceutical Industry
Overcoming the stress of non-prescription medicine application screening - Co...
Overcoming the stress of non-prescription medicine application screening - Co...
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
Regulatory requirement on dossier of medicinal products
Regulatory requirement on dossier of medicinal products
Registration of Indian Drug Product in Overseas Market.pptx
Registration of Indian Drug Product in Overseas Market.pptx
More from Guru Balaji .S
Basic Candlestick Pattern in stock market, finance
The document provides information on various candlestick patterns used in technical analysis of financial markets. It begins with definitions of basic candlestick types like doji and hanging man candles. It then outlines several reversal patterns like morning star and engulfing patterns that indicate a change in trend. Continuation patterns like rising three methods and falling three methods that suggest the current trend will persist are also discussed. The document provides illustrations and explanations of many common candlestick patterns to help readers understand how to interpret these visual representations of market price action.
Water
This document outlines various types and uses of purified water in pharmaceutical applications. It discusses drinking water that meets EPA or international standards which can be used directly if compatible. It then lists several typical water treatment steps like deionization, reverse osmosis, and distillation used to produce purified water for special pharmaceutical purposes like API processes. The document categorizes purified water products for uses such as hemodialysis, analytical reagents, cleaning/ingredients for non-parenteral dosage forms, and various sterile purified waters for injection, irrigation, inhalation after additional packaging and sterilization steps.
WO2017060920 a1
The document is an international patent application for pharmaceutical compositions of ibuprofen or its pharmaceutically acceptable salts. It summarizes various challenges with producing stable ibuprofen formulations, such as poor compressibility and adhesion during processing. The invention claims to provide a cost-effective method of producing ibuprofen granules with good flow properties and minimal weight variation through the use of glidants in three stages of formulation. It seeks patent protection for pharmaceutical compositions of ibuprofen and the process for their production.
Product registration procedure in USA
The document outlines the process for registering a pharmaceutical product in the USA, which includes developing and testing the product, submitting an ANDA application to the FDA for approval, producing validation batches at a larger scale once approved, launching the product commercially, undergoing facility inspections by the FDA periodically for compliance.
CMA-CPP-CQA for oral solid dosageform
This document discusses critical material attributes (CMA), critical process parameters (CPP), and critical quality attributes (CQA) for various pharmaceutical unit operations used in manufacturing oral solid dosage forms. It provides examples of CMAs, CPPS, and CQAs for common processes like blending, granulation, drying, compaction, and tableting. The goal is to identify material traits and processing conditions that most impact the critical quality standards of the finished drugs.
Specifications of process parameters and general ipc and finish product controls
This document outlines the critical process parameters and quality controls for various stages of manufacturing injectable products. It lists 7 key stages: 1) materials preparation, 2) compounding, 3) filtration, 4) filling, 5) lyophilization (if applicable), 6) final sterilization (if required), and 7) inspection. For each stage, critical process parameters are defined relating to temperature, time, pressure, flow rates, and other factors. Quality attributes of intermediate and finished products are also specified, including assays, pH, bacterial counts, and other attributes to ensure quality.
Generics drug approval and timelines in china
pharmaceuticals#validation#parameters#quality#China#pharma
#health
#medicine
#research
#manufacturing
#innovation
#research
#development
#Healthcare
#quality
#pharmacist
#technology
#CRO
#compliance
#counterfeits
#gurubalaji
ALCOA & ALCOA+
ALCOA & ALCOA+
#health
#medicine
#research
#manufacturing
#innovation
#research
#development
#Healthcare
#quality
#pharmacist
#technology
#CRO
#compliance
#counterfeits
#gurubalaji
Pharmaceutical process validation (PV)
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
Product development Global prospective
Product development Global prospective
pharmaceuticals#processvalidation#validation#parameters#quality##pharma
#health
#medicine
#research
#manufacturing
#innovation
#research
#development
#Healthcare
#quality
#pharmacist
#technology
#CRO
#compliance
#counterfeits
Pharma figures 2017 ; Efpia
The pharmaceutical industry is a key driver of scientific and medical progress. It invests billions annually in research and development to develop new medicines. In Europe, the industry invested an estimated €33.6 billion in R&D in 2015 and directly employs over 745,000 people. However, the industry faces challenges from fiscal austerity in Europe and increasing competition from emerging markets with fast-growing pharmaceutical sectors like Brazil and China.
CMA, CQA, CPP
CMA,CQA,CPP
pharmaceuticals#processvalidation#validation#parameters#quality##pharma
#health
#medicine
#research
#manufacturing
#innovation
#research
#development
#Healthcare
#quality
#pharmacist
#technology
#CRO
#compliance
#counterfeits
Points to be considered in topical formulation design
This document outlines key points to consider in topical formulation design, including the drug substance, excipients, physicochemical properties, container closure system, chemical and physical stability, manufacturability and scalability, preservative efficacy, and patient acceptance. Some important considerations are the quality and physical characteristics of the active pharmaceutical ingredient and excipients, ensuring compatibility between ingredients, and establishing a target product profile that maintains consistency of the formulation over time. Process parameters and equipment must also be identified during development to enable scalability and reproducibility of the commercial manufacturing process.
Topicals product development NDA,ANDA
The document discusses requirements for new drug applications and abbreviated new drug applications for topical products. A full NDA requires extensive safety studies including toxicity, skin irritation, and sensitization testing as well as two clinical efficacy studies and manufacturing controls. An ANDA for generic topical products requires abbreviated safety testing for skin irritation and toxicity along with manufacturing controls and either in vivo bioequivalence studies or in vitro release testing, and qualitatively and quantitatively matching inactive ingredients.
Comparasion of IND,NDA,BLA,ANDA,OTC
IND refers to investigational new drugs used in clinical trials. NDA and BLA are for approval of new drugs and biologics respectively, requiring clinical data. ANDA is an abbreviated application for generic drugs, needing bioequivalence data. OTC drugs are approved via monographs without premarket review or the orange/purple book.
Pharmaceutical QbD concepts for drug development
The document discusses quality by design (QbD) in pharmaceutical development. It defines QbD as a systematic approach that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. Under QbD, the desired product performance profile, target product quality attributes, and critical material attributes are defined to identify and control sources of variability. QbD provides increased flexibility while maintaining quality standards compared to traditional quality testing approaches. Key aspects of implementing QbD include knowledge management, risk management, designing controls based on scientific understanding, and continual improvement using knowledge gained over a product's lifecycle.
Generic product development with QbD pathway
This document outlines the key steps for generic drug product development using a Quality by Design (QbD) pathway, including supplier selection, API and excipient compatibility studies, process development from lab to pilot to pivotal scale, formula optimization at each stage, manufacturing demonstration batches, biostudies, stability testing, and e-CTD regulatory submission with defined quality target product profile, critical quality attributes, critical material attributes, and control strategy.
More from Guru Balaji .S (20)
Basic Candlestick Pattern in stock market, finance
Basic Candlestick Pattern in stock market, finance
Specifications of process parameters and general ipc and finish product controls
Specifications of process parameters and general ipc and finish product controls
Points to be considered in topical formulation design
Points to be considered in topical formulation design
Recently uploaded
LOOPS in orthodontics t loop bull loop vertical loop mushroom loop stop loop
vertical loop
horizontal loop
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Do you have abnormal smell after periods? It may be vaginitis. Do not worry, herbal medicine Fuyan Pill can help you get a cure.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Role of Mukta Pishti in the Management of Hyperthyroidism
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
It includes regulation of combination products and medical devices. FDA and industry liaisons.
TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd...
TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd Edition by DeMarco, Walsh, Verified Chapters 1 - 25, Complete Newest Version TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd Edition by DeMarco, Walsh, Verified Chapters 1 - 25, Complete Newest Version TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd Edition by DeMarco, Walsh, Verified Chapters 1 - 25, Complete Newest Version Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Chapters Download Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Download Stuvia Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Study Guide Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Ebook Download Stuvia Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Questions and Answers Quizlet Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Studocu Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Quizlet Test Bank For Community and Public Health Nursing: Evidence for Practice 3rd Edition Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Chapters Download Community and Public Health Nursing: Evidence for Practice 3rd Edition Pdf Download Course Hero Community and Public Health Nursing: Evidence for Practice 3rd Edition Answers Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Ebook Download Course hero Community and Public Health Nursing: Evidence for Practice 3rd Edition Questions and Answers Community and Public Health Nursing: Evidence for Practice 3rd Edition Studocu Community and Public Health Nursing: Evidence for Practice 3rd Edition Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Pdf Chapters Download Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Pdf Download Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Study Guide Questions and Answers Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Ebook Download Stuvia Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Questions Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Studocu Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Quizlet Community and Public Health Nursing: Evidence for Practice 3rd Edition Test Bank Stuvia
Part II - Body Grief: Losing parts of ourselves and our identity before, duri...
Learn about body grief and ways to cope with it. We will also explore methods to heal from this challenging experience.
Efficacy of Avartana Sneha in Ayurveda
Avartana Sneha is a unique method of Preparation of Sneha Kalpana in Ayurveda, mainly it is indicated for the Vataja rogas.
Recently uploaded (20)
LOOPS in orthodontics t loop bull loop vertical loop mushroom loop stop loop
LOOPS in orthodontics t loop bull loop vertical loop mushroom loop stop loop
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Post-Menstrual Smell- When to Suspect Vaginitis.pptx
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
Role of Mukta Pishti in the Management of Hyperthyroidism
Role of Mukta Pishti in the Management of Hyperthyroidism
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis - Definition , Evaluation and Management .pdf
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd...
TEST BANK For Community and Public Health Nursing: Evidence for Practice, 3rd...
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Part II - Body Grief: Losing parts of ourselves and our identity before, duri...
Part II - Body Grief: Losing parts of ourselves and our identity before, duri...
CTD ~ Common Technical Document
- 1. ICH CTD ASEAN CTD Description Remarks Module 1: Regional and administrativ e information Part I Region specific administrative documents like application form, legal documents(GMP, licenses, etc),labelling etc Required for generics and new drug Module 2: Overall summary Part II Module summarizes Module 3,4,and 5.It includes quality overall summary. Non clinical overview and summary and clinical overview and summary.Gives the abstract of documents provided in the whole application Required for generics and new drug.For generics summary on quality part only required Module 3: Quality Documents related to chemistry, manufacturing and control (CMC)of both drug substance and drug product Required for generics and new drug Module 4: Safety Part III Non clinical stability reports – Data on pharmacological, pharmakinetic and toxicological evaluation New required for generics Module 5: Efficacy Part IV Clinical study reports‐applicant provides a critical assessment of the clinical data and releated reports in the module Not required for generics except Bioequivalence (BE)study CTD ‐ Common technical document s.gurubalaji@gmail.com