1. FDA ICH Public Meeting 5630 Fishers Lane, Rockville, MD May 8, 2001 10:30 am -- 2:00 pm Implementation of the CTD Update-Issues-Next Steps Justina A. Molzon, M.S. Pharm., J.D. Associate Director for International Affairs Center for Drug Evaluation and Research U.S. Food and Drug Administration

2. CTD Expert Working Groups SAFETY EFFICACY QUALITY REGULATORY COMMUNICATIONS The CTD is the result of much hard work by many individuals

3. Organization of the CTD Module 1: Regional information Module 2: Quality Overall Summary Nonclinical Overview and Summary Clinical Overview and Summary Module 3: Quality Module 4:Nonclinical Study Reports Module 5:Clinical Study Reports

4. The CTD Triangle Module 1 Regional Admin Information Module 3 Quality Module 4 Nonclinical Study Reports Module 5 Clinical Study Reports Quality Overall Summary Nonclinical Summary Nonclinical Overview Clinical Summary Clinical Overview Module 2 NOT Part of the CTD The CTD

5. eCTD Six months behind CTD The eCTD will be a transport format intended to be moved into an agency’s review environment. Step 2 targeted for ICH meetings in Tokyo, May of 2001

6. CTD Implementation Issues Each ICH region is in the process of developing an implementation program Promote consistency between regions Transparency important Communication of progress on a regular basis

7. CTD Implementation Efforts Discussed by the Regulators at ICH5 Developed--Regulators Considerations for Implementation of the CTD –Harmonized and synchronized approach –Identify topics and mechanisms for discussion amongst regulators –Work with industry to establish implementation/monitoring task force(s)

8. CTD Implementation Efforts Target Date for acceptance for CTD –July 2001 Voluntary submission

9. CTD Implementation Issues - FDA Determining how the final CTD fits into our current regulatory scheme. May need changes in regulations. Considering general waiver.

10. CTD Implementation Questions - FDA How to incorporate region specific information into the CTD How to relate the CTD submission to information currently required How to apply the CTD to other FDA submissions for consistency

11. CTD Implementation Specifics- FDA General Considerations Guidance Guidance for Industry General Considerations for Submitting Marketing Applications According to the ICH/CTD Format To be issued in time for voluntary submission of applications in the CTD format

12. CTD Implementation Specifics- FDA General Considerations Guidance What we expect to be submitted Physical description of submission CTD requirements addressed List obsolete guidances Logistics of submission Timeframe

13. CTD Implementation Specifics- FDA General Considerations Guidance Module 1 Administrative & Prescribing Information includes: –FDA form 356h –Cover letter –Patent information –Debarment Certification –Field Copy certification –User Fee cover sheet –Financial disclosure information

14. CTD Implementation Specifics- FDA General Considerations Guidance Administrative and Prescribing Information Continued … –Letters of authorization for reference to other applications or drug master files –Patent Certification (not for BLA) –Waiver requests –Claimed Exclusivity –Labeling (package insert) –Container and package labels –Annotated labeling

15. CTD Implementation Specifics- FDA General Considerations Guidance General Issues for Submissions –Amendments and supplements –Organizing documents –Number of copies Archival Review Field –Paper size –Paper margins –Fonts

16. CTD Implementation Specifics- FDA General Considerations Guidance General Issues for Submissions continued –Binding volumes –Binder colors –Volume size –Volume identification –Pagination –Packing carton –Address for submission

17. CTD Implementation Specifics- FDA Training and Transparency Train reviewers and document room staff Map current process to that required by the CTD Create feedback mechanism for industry Provide updates on progress

18. THANK YOU