Dossier format and filing.pptx

Jan. 19, 2023

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Dossier format and filing.pptx

  1. Format & Contents of Dossier Filing Prachi Sharma M. Pharm. DRA I Sem
  2. Table of Contents • Dossier • Goals of Dossier Filing • Contents of Dossier • Format of Dossier • CTD • eCTD • ACTD • NeeS
  3. Dossier Dossier is a collection or file of documents on some subject, especially a file containing detailed information about a person or a topic. Dossiers are the vehicle in a country through which drug sponsors formally propose that the regulatory agencies approve a new pharmaceutical product. In pharmaceutical field, Dossier can be defined as a technical document on a pharmaceutical product for human use that has to go through the reviewing and assessment.
  4. Goals of Dossier filing A dossier enables the regulatory agencies t review and evaluate every minor information abut the proposed pharmaceutical product, to seek answers for the following questions: • Is the drug safe and effective in its proposed use, when used as directed? • Do the benefits of the product outweigh the risks associated? • Is the drug product’s labelling appropriate?
  5. • Are the methods used in manufacturing the drug maintain the quality, strength and purity od the product? • What does the drug product contains (i.e., ingredients)? In short, the key goal of the dossier filing is to ensure the quality, safety and efficacy of the drug product
  6. Contents of Dossier • Data providing that the drug has quality, efficacy, and safety properties suitable for the intended use. • Any additional administrative documents (SMF, DMF, PDP, MFR, BMR, etc.) • Samples of finished products • Related substances and reagents necessary to perform analysis of finished product.
  7. Format of Dossier • Every country has its own rules and regulations for the submission and format of dossier. Hence, it is mandatory to possess the knowledge about exact regulatory requirements of the particular country. • Because the submission of application that does not comply with the guidelines may result in delays, queries, and rejection. Formats for dossier submission: • CTD • eCTD • ACTD
  8. CTD A Common Technical Document is the most commonly accepted format of the dossier. CTD was officially signed off in November,2000 at the 5th ICH Conference, California. CTD format is widely accepted in Semi regulated and regulated countries. CTD is accepted for filing: • INDs (Investigational New Drugs) • NDAs (New Drugs Applications) • ANDAs (Abbreviated New Drug Applications) • BLAs (Biologicals License Applications) There are five modules in CTD:
  9. eCTD eCTD is nothing but the electronic form of CTD. Generally, eCTD can be defined as a standard format of submitting the application for application to the concerned regulatory agency. An eCTD consists of individual documents in PDF format which are arranged in a hierarchical form as per CTD structure. Just like CTD, eCTD also comprises of five modules and is accepted for all those purposes that are fulfilled by CTD i.e., • NDAs • INDs • ANDAs • BLAs
  10. ACTD ACTD is ASEAN Common Technical Document. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed-upon common format for the preparation of a well- structured Common Technical Dossier (CTD) application which was submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. ASEAN is a CTD document for South East Asian Countries. A bunch of 10 countries came together to lay down their own rules and regulations for dossier submission.
  11. ASEAN Countries A bunch of 10 countries came together to join hands and lay down their own rules and regulations for dossier submission. List of 10 ASEAN Countries: 1. Laos 2. Burma (Myanmar) 3. Brunei 4. Cambodia 5. Malaysia 6. Singapore 7. Thailand 8. Phillippines 9. Vietnam 10. Indonesia
  12. ACTD Format The ACTD consists of four parts. These four parts contain all the information required by the regulatory agencies to be submitted by the applicant. Part 1: Table of Content, Administrative Data and Product Information: This part contains all the relevant information regarding the whole ACTD to provide basis details. A general introduction to the pharmaceutical product, its class, mode of action, etc. Part 2: Quality Document: This part provides the overall summary and the study reports.
  13. Part 3: Non-Clinical Document: Part III provides the non-clinical overview, written summaries and tabulated summaries. But for ASEAN countries, these study reports may not be required for Major Variation Products if the original product is already registered and approved in Reference Countries. Part 4: Clinical Document: Part IV provides the Clinical overview and clinical summary. This document is not needed for generic products.
  14. NeeS NeeS is Non-electronic CTD Submission. NeeS is a n electronic document generated in PDF format submitted in a CD. NeeS differs from CTD as it does not contain: • The XML files that provide the backbone to the CTD format. NeeS format comprises: • Table of Contents • A NeeS format must contain a Table of Content in PDF form
  15. • Hyperlinks & Bookmarks: To locate the content quickly and effectively, hyperlinks and bookmarks are added to the NeeS. The use of these are recommended: • To assist the regulatory body to navigate them through the PDF • Clarity to the document