Pharma regulatory affairs

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Introduction to Pharma regulatory affairs

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Pharma regulatory affairs

  1. 1. Pharma Regulatory AffairsGirish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
  2. 2. Regulatory AffairsGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 2 of 27
  3. 3. Role of RA To keep track of the ever- changing legislation Registration documents to regulatory agencies To i T give strategic and t h i l t t i d technical advice to R&D, Production, QC dept etc.Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 3 of 27
  4. 4. You should know What Wh t is i Dossier ? D i What is DMF ? What is CTD / eCTD ? What is NDA / ANDA and MAA ?Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 4 of 27
  5. 5. What is Dossier ? Dossier i a collection or fil of d D i is ll i file f documents that h contains all the technical data of pharmaceutical p product to be approved / registered / marketed in pp g a country. It most commonly called as Registration Dossier, In US : New Drug Application (NDA), In EU : Marketing Authorization Application (MAA)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 5 of 27
  6. 6. What is DMF ? Drug Master File (DMF) US United State Drug Master File (US-DMF) EU European Drug Master File (EDMF) or Active Substance Master File (ASMF) [Applicant’s Part / Open Part and Restricted part / Closed part]DMF TypesType I – Mfg. Site, Facilities, Operating Procedures, and Personnel (no longer applicable)Type II - DS, Intermediate & Material Used in Their Preparation or Drug ProductType III - Packaging MaterialType IV - Excipient, Colorant, Flavor or Material Used in Their PreparationType V - FDA Accepted Reference Information (FDA discourages its use)Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 6 of 27
  7. 7. What is CTD/eCTD ? Common Technical Document (CTD): Its an format set by ICH which was agreed by the Regulatory Agencies of Europe, Japan & the US. Its electronic version called as electronic Common Technical Document (eCTD).Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 7 of 27
  8. 8. The CTD TriangleGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 8 of 27
  9. 9. CTD Modules Module 1 – Administrative Information (Region Specific) Module 2 – CTD Summaries (QOS) Module 3 – Quality (CMC) Module 4 – Non-Clinical Study Reports y p Module 5 – Clinical Study ReportsGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 9 of 27
  10. 10. Module 1 Administrative Information (Region Specific) Should contain documents specific to each region For USA For EU Application form 356h Application form Proposed l b l d label Summary of product characteristics Patent certification / Labelling text and mock-ups information Information about the experts Debarment certificate Environmental risk assessment Letter of Authorization (LoA)/ DMF letter Description of the pharmacovigilance system Labeling text Risk management planGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 10 of 27
  11. 11. Module 2 odu e CTD Summaries (QOS) It contain 7 sections in the following order: 2.1 CTD TOC (Module 2-5) 2.2 2 2 CTD Introduction 2.3 Quality Overall Summary 2.4 Non-clinical 2 4 Non clinical Overview 2.5 Clinical Overview 2.6 Non-Clinical 2 6 Non Clinical Summary 2.7 Clinical SummaryGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 11 of 27
  12. 12. Module 3 Quality (CMC) 3.1 3 1 TOC of M d l 3 f Module 3.2 Body of Data 3.2.S - Drug substance 3.2.P - Drug product 3.2.A - Appendices d 3.2.R - Regional Information 3.3 3 3 Literature references fGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 12 of 27
  13. 13. Module 4 Non-Clinical Study Reports 4.1 4 1 TOC of M d l 4 f Module 4.2 Study reports 4.2.1 Pharmacology 4.2.2 Pharmacokinetics 4.2.3 Toxicology l 4.3 Literature ReferencesGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 13 of 27
  14. 14. Module 5 Clinical Study Reports 5.1 5 1 TOC of Module 5 5.2 Tabular listing of Clinical Studies 5.3 Clinical study reports 5.3.1 Reports of Biopharmaceutical (BA-BE) Study 5.3.2 Reports of Pharmacokinetic (biomaterial) study 5.3.3 Reports of Pharmacokinetic (PK) Studies 5.3.4 Reports of Pharmacodynamic (PD) Studies 5.3.5 Reports of Efficacy and Safety studies 5.3.6 Reports of Post-Marketing experience p g p 5.3.7 Case Report Forms & Individual patient listings 5.4 Literature ReferencesGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 14 of 27
  15. 15. eCTD Its electronic version of CTD so called as CTD, electronic Common Technical Document (eCTD). eCTD composed of two types of specification Content specification – As defined by ICH p y Technical specification – Electronic softwaresGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 15 of 27
  16. 16. eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing From year 2010 European Union also make y p compulsory for electronic CTD submission to all proceduresGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 16 of 27
  17. 17. eCTD CharacteristicsStructure All Modules 1 to 5 have granularity options. PDF documents linked via XML backbone Increased document granularity granularity. Transparency of entire submission Ease of navigation and reviewGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 17 of 27
  18. 18. eCTD TemplateGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 27
  19. 19. M1Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 27
  20. 20. M2Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 27
  21. 21. M3Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 21 of 27
  22. 22. M4Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 22 of 27
  23. 23. M5Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 23 of 27
  24. 24. Benefits of eCTDGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 24 of 27
  25. 25. Cou Country wise Regulatory age cy y se egu a o y agency websites India www.cdsco.nic.in http://www.cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf USA http://www.fda.gov/drugs/default.htm h // fd /d /d f l h Orange book:http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm European Home page: www.emea.europa.eu Guidelines page: http://www.emea.europa.eu/htms/human/humanguidelines/quality.htm UK Home page: www.mhra.gov.uk Guidelines page: http://www.mhra.gov.uk/Publications/Regulatoryguidance/index.htm Australia Home page: www.tga.gov.au Guidelines page: http://www tga gov au/pmeds/pmeds htm http://www.tga.gov.au/pmeds/pmeds.htmGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 25 of 27
  26. 26. Cou Country wise Regulatory age cy y se egu a o y agency websites (cont.)International conference on harmonization (ICH) ( )Home page: www.ich.orgGuidelines page: http://www.ich.org/cache/compo/276-254-1.htmlCanadaHome page: www.hc-sc.gc.caH hGuidelines page: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/index-eng.phpSouth AfricaHome page: http://www.mccza.comGuidelines : http://www.mccza.com/showdocument.asp?Cat=17&Desc=Guidelines%20- %20Human%20MedicinesSingaporeHome page: www.hsa.gov.sgH hGuidelines : http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/regulatory_guidances.htmlBrazilHome page: http://www.anvisa.gov.br/eng/index.htm p g p // g / g/Guidelines page: http://www.anvisa.gov.br/eng/legis/index.htm#3 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 26 of 27
  27. 27. Thank Th k youGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 27 of 27

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