1. Registration and Harmonisation in the Area of Medical Products in Switzerland Swiss Russian Health Forum Basel, 10./11. September 2012 Dr. Petra Dörr Head of Management Services & Networking Member of the Management Board Swissmedic, Swiss Agency for Therapeutic Products

2. Overview 2 Swissmedic: a short Introduction Marketing Authorisation in Switzerland International Cooperation and Harmonisation Summary

3. Swissmedic: a short Introduction Mission Our competence – for your trust in therapeutic products We are the Swiss agency for the authorisation and supervision of therapeutic products. We fulfil our legal mandate and work with partner authorities on a national and international basis. We endeavour to ensure that authorised therapeutic products are of high quality, effective and safe. By doing so, we make a considerable contribution towards protecting the health of humans and animals, and we also participate in safeguarding Switzerland as a location for industry and research. 3

4. Swissmedic: a short Introduction Established in January 2002 as the first Federal authority on therapeutic products along with the coming into force of the Act on Therapeutic Products Prior to 2002, regulation of medicinal products was a cantonal responsibility Scope of products Medicinal products for human and veterinary use (Chemical, biotechnology, biologic, stable blood products, transplant products, traditional and herbal medicines, …) Medical devices (based on EU system, Notified Bodies and CE-marking) 4

5. Swissmedic: a short Introduction Areas of responsibility Marketing authorisation (medicinal products) Market surveillance (medicinal products and medical devices) Inspections, licenses Control of narcotics Laboratory controls / Official Medicines Control Laboratory Enforcement / Criminal penalisation Drafting of laws and standards Provision of information on therapeutic products 5

6. Swissmedic: a short Introduction Key figures Staff:360 full-time equivalents 430 people Budget:80 Mio. CHF Federal contribution:≈ 20% Fees:≈ 80% 6

7. Marketing Authorisation in Switzerland: Basics/Background National marketing authorisation Medicinal products have to be authorised by Swissmedic before they can be marketed in Switzerland Switzerland – not being a member of EU/EEA – does not participate in EU-marketing authorisation procedures 7

8. Marketing Authorisation in Switzerland: Approach Applications for innovative medicinal products, e.g. with new active substances Swissmedic conducts its own assessment (as a general rule) Applications for non-innovative medicinal products, e.g. generics/ known active substances Swissmedic should consider assessments of other well- recognised regulatory authorities, such as European Medicines Agency (EMA), US-Food and Drug Administration (US-FDA), etc. 8

9. Marketing Authorisation in Switzerland: Procedures Swissmedic currently applies two basic procedures Regular marketing authorisation procedure Fast-track procedure Criteria: treatment of life-threatening or chronically debilita- ting illness, no or no sufficient treatment options available, high expected therapeutic benefit (“unmet medical need”) In 2013, an additional route will become available: the procedure with advance notification for innovative medicines, not fulfilling the criteria for a fast-track procedure 9

10. Marketing Authorisation in Switzerland: Procedures 10 Submission Validation (VAL) completed Documents OK List of Questions (LOQ) „Approvable letter“ (AL) Decision „Verfügung“ VALAD* Review phase I Response to AL Labelling Response to LOQReview phase II Receipt of response to LOQ Receipt of Response to AL 30 10 max.10120 100 60 max. 9090 50 max. 9090 70 20 Swissmedic times (Submission to decision): Regular Procedure: 330 calendar days Procedure with advance notification (2013): 270 calendar days Fast-track procedure: 140 calendar days Company time Swissmedic-time *AD = Amendment of documentation

11. Marketing Authorisation in Switzerland: Requirements Documentation Common Technical Document (International Conference on Harmonisation; ICH CTD) “State of the Art” ICH Guidelines EMA/FDA technical guidelines Specifics Labelling (2-3 languages) 11

12. International Cooperation & Harmonisation 13 Why international cooperation? Implementation of international treaties Ensuring drug safety/mutual benefit from early risk-communication Building mutual trust Increasing efficiency/create synergies Harmonisation of requirements Reduction of technical barriers to trade Maintaining international reputation Motivation of staff  Need to network globally on an agency level as regulated industry is also operating globally

13. International Cooperation & Harmonisation Swissmedic: Basis for international cooperation Act on Therapeutic Products (Art. 64 ATC: International Administrative Assistance Mandate (Federal Council; four years; strategic goals) Service Agreement (Department of the Interior; objectives on an annual basis) Strategy paper on national and international cooperation (approved by the Council of the Institute in May 2008) 12

14. International Cooperation & Harmonisation 14 Swissmedic Strategy Prioritisation/selection: we are small - we have to focus on key partners/activities … towards global leading agencies: consideration/reliance, staff and information exchange, peer review … towards partner agencies: consideration/reliance, staff and information exchange, peer review, towards work sharing … towards developing agencies: provision of information/training Support of WHO activities Harmonisation of requirements: collaboration in international standard setting organisations FDA Swissmedic HSA Swiss- medic XXX Swiss- medic

15. International Cooperation & Harmonisation 15 Bilateral activities Mutual Recognition Agreements (MRA): Canada, EU, EEA/EFTA Memoranda of Understanding (MOU): Food and Drug Administration, USA (2003) Health Products and Food Branch, Canada (2006) Therapeutic Goods Administration, Australia (2006) Health Sciences Authority, Singapore (2008) Medsafe, New Zealand (2009) Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Japan (2010) Irish Medicines Board, Ireland (2011) Paul-Ehrlich Institut, Germany (2012)

16. International Cooperation & Harmonisation 16 Multilateral activities International Regulators Consortium (Australia, Canada, Singapore, Switzerland) World Health Organization: Pre-Qualification, trainings, Blood Regulators Network, Paediatric medicines Regulators Network PFIPC (Permanent Forum on International Pharmaceutical Crime) Council of Europe/European Pharmacopoeia

17. International Cooperation & Harmonisation 17 Harmonisation & standard setting organisations International Conference on Harmonisation (ICH, www.ich.org)www.ich.org Harmonised requirements for the registration of medicinal products for human use Global Harmonisation Task Force (GHTF, www.ghtf.org)www.ghtf.org Harmonised requirements for medical devices Pharmaceutical Inspection Cooperation Scheme (PIC/S), World Health Organisation (WHO), Organisation for Economic Cooperation and Development (OECD), …

18. Summary 17 Swissmedic’s mandate comprises medicinal products and medical devices and is based on the Act on Therapeutic Products Swissmedic does not participate in EU-marketing authorisation procedures but grants national Swiss marketing authorisations Swissmedic conducts an independent assessment for innovative medicines International cooperation between regulators is paramount, as industry is also globalised International cooperation has to be focussed and tailored to the specific national situation

19. 19 Thank you for your attention… Questions? Dr. Petra Dörr Petra.doerr@swissmedic.ch