1. Swissmedic Swiss Agency for Therapeutic Products Hallerstrasse 7 CH-3000 Bern www.swissmedic.ch Swissmedic’s future steps 2nd Follow-up Information Meeting with Workshops – Step 3 Dr. Adrian Tschannen 16th March 2011

2. 2 Gain experience!  Promote use of existing eCTD  Cooperate with industry  Broader use of eCTD  Higher efficiency in validation

3. 3 Gain experience! Promote use of existing eCTD  Cooperate with industry  Broader use of eCTD  Higher efficiency in validation

4. 4 eCTD: Impressive reduction of paper in 2010 induced by eCTD: 30 % savings Significant benefit for Swissmedic and Industry!

5. 5 Promote use of existing eCTD There is potential to expand eCTD usage by 85 %! Status of eCTD applications per February 15, 2011 : Approx. 15% (95 out of 645) of all initial marketing authorisation applications are electronic-only submissions. Swissmedic official recommendation: Use eCTD Initial Marketing Authorisations:  Generika: Generics  NAS: New Active Substance  BWS: Known Active Substance  NA div.: consists of: NKO (New combination), NDO (New Dosage Strength), NGF (New Dosage Form), NDE (New Dosage Recommendation), IE (New Indication)

6. 6 Keep and Improve quality of eCTD applications  Secure proper lifecycle  Pass technical validation “at first go” and without restrictions  Deepen eCTD know-how and reduce effort to generate, submit (application holders) and receive, process (Swissmedic)

7. 7 Gain experience!  Promote use of existing eCTD  Cooperate with industry  Broader use of eCTD  Higher efficiency in validation

8. 8 Electronic application form  Web based forms  Information submitted by applicant: -directly fills in regulatory databases (integration to Swissmedic core systems)  User-friendly interface for applicants -pre-populating fields -field validation -controlled term dictionaries  Open questions -XML forms (structured information instead of pdf / text data) -> move from document management to content management -…and more…

9. 9 User identification  Electronic User identification & electronic signature Benefit: Replace paper, accelerate communication Examples of current paper forms and documents, potentially to be removed by electronic information exchange Reception of applicationPreliminary decision and feedback Confirmation of receiptLabelling Follow-up questions and answersOfficial decisions (decrees) PublicationsInvoicing Access to application status… Reports from External Reviewers (Experts) List of Questions and responses

10. 10 Gateway  Web Portal for submissions, including upload of eCTD  “Track & Trace”: Easy access to submission status  Elimination of security issues with transport of CDs / DVDs  “Online” technical validation (“pass or fail”)  Benefits: -Speed up authorization procedure, -Increase transparency regarding ongoing submission

11. 11 Better communication  eCTD next major version: Several topics are in discussion for further development of eCTD, becoming ISO standard -two-sided exchange of information (e.g. LOQ) -PDF 1.7 with enhanced functionality and less limitations (e.g. multimedia) -XML forms (structured information instead of pdf / text data)  Optionally expand collaboration between agencies

12. 12 Gain experience!  Promote use of existing eCTD  Cooperate with industry  Broader use of eCTD  Higher efficiency in validation

13. 13 Broader use of electronic application procedure: Example Veterinary products  Integrate Veterinary products  But there are several open questions: -Standards are not clear: Deviate from eCTD: Integration eNTA, VNeeS? -Manage 2 or 3 systems (paper, VNeeS, eNTA) is not easy on a long term -Wait on EU experiences? FAQ see: http://esubmission.emea.europa.eu/tiges/vet esub.htm http://esubmission.emea.europa.eu/tiges/vet esub.htm -Swissmedic will evaluate 2011

14. 14 Gain experience!  Promote use of existing eCTD  Cooperate with industry  Broader use of eCTD  Higher efficiency in validation

15. 15 Product Information Management http://pim.ema.europa.eu/  Bidirectional: used for exchange of comments, changes and version control  XML Structure  Standardized terms / warnings (text patterns)  Online publication as an option

16. 16 eCTD in relation to Swissmedic Core System and Document Management  Integrated Swissmedic IT systems: Connect core system to eCTD database and electronic Document Management System  Use Meta Data in the Document Management System for easier information search and access  Fulltext search (like “Google”) over different document types to facilitate Swissmedic knowledge management

17. 17 Gain experience!  Promote use of existing eCTD  Cooperate with industry  Broader use of eCTD  Higher efficiency in validation Swissmedic IT Roadmap Yes we can – but not all at the same time!

18. 18 ProgrammJahr Quartal 2010201120122013201420152016 …. 3412341234123412341234 Document Management eGovernment Fachspezifische Anwendungen Swissmedic IT Roadmap 2011 – 2015 (extract) Portals eCTD SIMES 3Document Mgmt El. Signature Product Information eCTD SIMES 4 Electronic application form, Track & Trace New version of eCTD with enhanced functions e.g. bidirectional data exchange Electronic Product Information Management Full eCTD lifecycle supported by Swissmedic Electronic Document Management System Swissmedic Promote use of existing eCTD; Keep and Improve quality Swissmedic IT Roadmap is intended to be used as a planning assumption and is subject to annual revision according to the particular project progress and future strategic priorities. Electronic Documents Exchange

19. 19 Thank you for your attention Dr. Adrian Tschannen Head of Sector Infrastructure Member of the Management Board Swissmedic adrian.tschannen@swissmedic.ch