CTD and eCTD

COMMON TECHNICAL DOCUMENT AND ELCTRONIC COMMON TCHNICAL DOCUMENT

1. Presentation by : Pawankumar Hanamant Yadav 1 st year M. Pharm ( sem –l) Dept. : Pharmaceutics Guided by : Mr. K. J. Kore Subject : Regulatory Affairs RAJGAD DNYANPEETH’s COLLEGE OF PHARMACY , BHOR

2. CTD AND eCTD

3. Introduction Organisation of CTD eCTD eCTD characteristics Benefits of eCTD Comparison CONTENTS:

4. Common Technical Document [CTD]: It is an format set by ICH which was agreed by the Regulatory Agencies of Europe , Japan & the U.S. • The FDA characterized the CTD as “An information package of clinical, non clinical , manufacturing , technical data in the same content that would be submitted for registering new drugs in all 3 ICH regions i.e. U.S,European Union and Japan CTD

5. • It should be organized into 5 modules Module 1 – Administrative Information [Region Specific] - Module 2 – CTD Summaries[QOS] - Module 3 – Quality[CMC] -Module 4 – Non clinical study reports - Module 5 – Clinical study reports Organisations Of CTD

6. • This module should contain documents specific to each region • Ex : Application form regarding the prescribing information, proposed label • This module is not part of the CTD. •The content & format of this module can be specified by the relevant regulatory authorities. MODULE 1 Administrative Information [Region Specific]

7. MODULE 2 CTD Summaries [QOS] • It should begin with a general introduction to the pharmaceutical , including its pharmacological class , mode of action & proposed clinical use. i.e. information should not exceed one page • It contain 7 sections in the following order: 2.1 CTD TOC [Module 2 – 5] [Table Of Content] 2.2 CTD Introduction - 2.3 Quality Overall Summary

8. 2.4 Nonclinical overview 2.5 Clinical overview 2.6 Non clinical summary 2.7 Clinical summary • The organization of these summaries is described in 3 separate documents: A] M4 Q – The CTD quality B] M4 S - The CTD Safety C] M4 E - The CTD Efficacy

9. MODULE 3 Quality [CMC] • 3.1 TOC of Module 3 • 3.2 Body of Data 3.2.S -Drug substance 3.2.P – Drug product 3.2.A – Appendices 3.2.R –Regional information • 3.3 Literature references

10. MODULE 4 Non Clinical Study Reports • 4.1 TOC of Module 4 • 4.2 Study reports 4.2.1 pharmacology 4.2.2 pharmacokinetics 4.2.3 Toxicology • 4.3 Literature References

11. MODULE 5 Clinical Study Reports • 5.1 TOC of Module 5 • 5.2 Tabular listing of clinical studies • 5.3 Clinical study reports -5.3.1 Repots of biopharmaceutical study[BA-BE] -5.3.2 Reports of PK [biomaterial] study -5.3.3 Reports of PK studies -5.3.4 Reports of PD studies -5.3.5 Reports of Efficacy and safety studies -5.3.6 Reports of Post marketing experience -5.3.7 Case Report forms & Individual patient listings • 5.4 Literature References

12. eCTD • It is electronic version of CTD , so called as electronic common technical document [e CTD] • e CTD composed of 2 types of specification Content specification – As defined by ICH Technical specification- Electronic softwares CTD TOC [ pdf ] [paper] eCTD XML Backbone

13. eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing From year 2019 European Union also make compulsory for electronic CTD submission to all procedures CTD eCTD Module 1 m1 Module 2 m2 Module 3 m3 Module 4 m4 Module 5 m5

14. • Structure -All Modules 1 to 5 have granularity options. -PDF documents linked via XML backbone. -Increased document granularity. -Transparency of entire submission. -Ease of navigation and review. eCTD Characteristics

15. Benefits of eCTD Improve reviewer efficiency. Can reduce time to approval. Improved handling and achieving of submissions(both sponsor and FDA). Search functionality and increased tracking ability. Allows for repurposing of docs for submission in other regions. Accessibility to docuents across modules. Submission via ESG allows immediate receipt by FDA.

16. COMPARING PAPER CTD AND e CTD Paper CTD eCTD Compiled electronically with volumes, tabs, sheets, then printed to paper. Complied electronically with a documents in folders. Paper volumes must be A4. eDocuments can be A4 or US letter size. CTD navigations by TOCs and volume. eCTD navigation by XML backbone. Manual document navigation by TOCs, page numbers, caption cross references. Electronic document navigation by TOCs, bookmarks and hyperlinks. Cross reference includes target CTDsection number. Cross references are hyperlinked to targets. Submitted in binders in boxes on pallets by trucks. Submitted on CD or DVD or by email or portal.

17. THANK YOU