1. Swissmedic Swiss Agency for Therapeutic Products Hallerstrasse 7 CH-3000 Bern www.swissmedic.ch Workshop 2 - Paragraph 13 TPA 2nd Follow-up Information Meeting with Workshops – Step 3 Dr. Cornelia Bigler, Swissmedic Jörg Schnitzler, Astellas 16th March 2011

2. 2 Overview 1.Formal Preparation of the Submission 2.Technical Preparation 3.Pro‘s and Con‘s of Submissions according to Paragraph 13 4.Tips and Tricks, Questions

3. 3 Formal Preparation of the Submission (I) Example-Pill  Application type: na-ngf  Galenic Form: Tablets  Paragraph 13: yes  Central European Authorisation

4. 4 Formal Preparation of the Submission (II) Questions  What documents do I have to consider?  Put the milestones in the right order

5. 5 Formal Preparation of the Submission (III) Questions  Which application types can be submitted according to paragraph 13 TPA in eCTD Format?  Which applications can lead to a faster approval?

6. 6 Formal Preparation of the Submission (IV) Question  What forms do I have to submit?  http://www.swissmedic.ch/org/ 00064/00067/00331/00631/in dex.html?lang=en

7. 7 Formal Preparation of the Submission (V) Questions  What documents regarding correspondance do I have to submit if the application is based on an EU-CP?  Where do I put FDA Assessment Reports?

8. 8 Formal Preparation of the Submission (VI) Questions  Where do I find the requirements for Module 1?  Where do I find an example of a tracking table?

9. 9 Formal Preparation of the Submission (VII) Questions  Can primary and secondary packaging of the product in Switzerland differ from the one authorised in the EU?  What other differences between the authorisation in a foreign country and the application submitted to Swissmedic are allowed?

10. 10 Formal Preparation of the Submission (VIII) Questions  How do I maintain the lifecycle after approval? Variation of product information

11. 11 Overview 1.Formal Preparation of the Submission 2.Technical Preparation 3.Pro‘s and Con‘s of Submissions according to Paragraph 13 4.Tips and Tricks, Questions

12. 12 Technical Preparation – Initial Application Questions Example: an existing EU dossier approved in 2007  How to prepare the inital application?  Which documents are required beside the reference dossier?

13. Paragraph 13 – Initial Submission of Reference Dossier and Swiss M1 Reference Dossier (e.g. EU) Swiss Dossier Exact copy of all approved sequences (reference dossier will not undergo technical validation) At the time of the initial paragraph 13 application Swiss eCTD consists only of the Swiss Module 1 13

14. 14 Technical Preparation - Consolidation Questions Paragraph 13 granted for dossier – next step:  How to combine Swiss eCTD and reference dossier for future lifecycle?

15. Paragraph 13 – Incorporating Reference M2-5 Life Cycle into Swiss eCTD Reference Dossier (e.g. EU) Swiss Dossier CH M1 Current approved status Future life cycle just in Swiss eCTD 15

16. 16 Technical Preparation - Correspondence Questions  How to include Module 1 documents from the reference dossier into the Swiss eCTD in M1?  How to include correspondence between applicant and reference country?  What should be hyperlinked?

17. Paragraph 13 eSubmission – merge dossiers Copy as new document Delete EU M1 Include 1.7 Merge reduced EU with §13 CH M1 Reference Dossier (e.g. EU) 17

18. 18 Overview 1.Formal Preparation of the Submission 2.Technical Preparation 3.Pro‘s and Con‘s of Submissions according to Paragraph 13 4.Tips and Tricks, Questions

19. Pro’s of Submissions according to Paragraph 13 (I)  Quick preparation of initial dossier possible as just Swiss Module 1 and an exact copy of reference dossier required.  Reference dossier can be used for initial application without any changes or rework (content validation, no technical validation).  Merging of reference dossier and Swiss eCTD while process ongoing (i.e. without clock-stop). 19

20. Pro’s of Submissions according to Paragraph 13 (II)  Free-of-charge validation tools allow to check upfront for technical compliance of submission.  Even submissions in NeeS or paper can be submitted according to Paragraph 13, but require more rework in order to merge life cycles.  Parallel submission in Switzerland and reference country and later switch to Art 13 after successful approval in reference country possible. 20

21. Con’s of Submissions according to Paragraph 13 (I)  Limitation to dossiers approved within the last 5 years.  Technical rework might be required to ensure compliance with latest validation criteria for older dossiers (up to 5 years) when merging M2-5 of the reference dossier into the Swiss eCTD. 21

22. Con’s of Submissions according to Paragraph 13 (II)  Correspondence between applicant and reference country and specific Module 1 documents e.g. Response to Questions need to be provided as part of the Swiss eCTD.  In case of contradictory assessments in the reference countries (e.g. different assessment in US vs. EU) Swissmedic carries out its own evaluation. 22

23. 23 Overview 1.Formal Preparation of the Submission 2.Technical Preparation 3.Pro‘s and Con‘s of Submissions according to Paragraph 13 4.Tips and Tricks, Questions

24. 24 Swissmedic’s Review Tool

25. Technical Hurdles Rework of reference dossier required?  Up to 5 years old  Valid according to older validation criteria?  Valid according to latest validation criteria?  PDF v1.4  Hyperlinks QCed after merging into CH eCTD?  ‘Incorrect’ filenames  Node-extensions  Differences in validation reports 25

26. 26 Tips and Tricks  Hyperlinking of product information is not required  Module 1.7.1: EU Responses to LoQ, not only for EMA, but also for DCP (no Hyperlinking required)  Evaluation report(s), other assessments and the related correspondence that led to the decisions of the reference authority have to be submitted in full (VAM Art 5a, section 1)  Read the guidance and supporting documents

27. 27 Thank you for your attention! Any Questions?