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CTD and eCTD

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Introduction to CTD and eCTD submissions

Introduction to CTD and eCTD submissions

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  • 1. CTD and eCTDGirish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
  • 2. 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 2 of 20
  • 3. The CTD TriangleGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 3 of 20
  • 4. 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 4 of 20
  • 5. 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 5 of 20
  • 6. 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 6 of 20
  • 7. 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 7 of 20
  • 8. 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 8 of 20
  • 9. 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 9 of 20
  • 10. 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 10 of 20
  • 11. 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 11 of 20
  • 12. 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 12 of 20
  • 13. eCTD TemplateGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 13 of 20
  • 14. M1Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 14 of 20
  • 15. M2Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 15 of 20
  • 16. M3Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 16 of 20
  • 17. M4Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 17 of 20
  • 18. M5Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 20
  • 19. Benefits of eCTDGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 20
  • 20. Thank Th k youGirish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 20