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Pharma regulatory affairs

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Introduction to Pharma regulatory affairs

Introduction to Pharma regulatory affairs

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  • sir, will you please send me thiz ppt on my mail add : shweta.bisht23@gmail.com
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  • Dear sir, can you please send me this ppt file for reference my email is: grajhasekar@gmail.com. Thanks
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  • Hello girish sir, i kindly request you to forward me the above slides hoping you may forward me the slides my id is sri.oscular7@gmail.com EAHERLY AWAITING FOR YOUR RESPONSE THANKING YOU SIR
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  • Dear sir,
    can you please send me this ppt file for reference
    my email is: sachin51090@gmail.com
    thank you very much!
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  • 1. Pharma Regulatory AffairsGirish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
  • 2. Regulatory AffairsGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 2 of 27
  • 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. 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. 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. 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 Site, Facilities, Operating Procedures, and Personnel (no longer applicable)Type II - DS, Intermediate & Material Used in Their Preparation or Drug ProductType III - Packaging MaterialType IV - Excipient, Colorant, Flavor or Material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. 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. The CTD TriangleGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 8 of 27
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. eCTD TemplateGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 27
  • 19. M1Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 27
  • 20. M2Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 27
  • 21. M3Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 21 of 27
  • 22. M4Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 22 of 27
  • 23. M5Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 23 of 27
  • 24. Benefits of eCTDGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 24 of 27
  • 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. 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. Thank Th k youGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 27 of 27

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