Switzerland
Swiss Agency for Therapeutic Products (Swissmedic)
Switzerland is regulated by Swissmedic, the Swiss Agency for Therapeutic Products, an independent public-law institution operating outside the EU regulatory framework. Marketing authorisation is granted under the Therapeutic Products Act (TPA, Heilmittelgesetz / HMG) of 15 December 2000. Although outside the EU, Switzerland is a strong reliance regulator: Swissmedic accepts foreign approvals from FDA, EMA, MHRA, Health Canada, TGA, and PMDA via the Article 13 reliance procedure (Verfahren mit Voranerkennung) and the ACCESS Consortium pathway. A landmark 2024 reform (Swissmedic Reliance Procedure for ATMPs) further extended reliance to advanced therapy medicinal products. Switzerland operates a Mutual Recognition Agreement with the EU on GMP and pharmacovigilance inspections. Pricing and reimbursement are decided separately by the Federal Office of Public Health (FOPH/BAG) on the Speciality List (SL), with reference pricing against 9 European countries.
About the authority
Swissmedic is a federal institution under public law, headquartered in Bern, that supersedes the cantonal Intercantonal Office for the Control of Medicines (IKS) since 2002. It regulates human and veterinary medicinal products, transplant products, and certain medical devices. Funded by application fees, supervisory fees, and a federal contribution. Swissmedic operates an MRA on GMP with the EU and is a PIC/S founding member.
International affiliations
Reliance & recognition
Switzerland operates the Article 13 reliance procedure as a formal reduced-evaluation pathway. Swissmedic also participates in the ACCESS Consortium (with HC, MHRA, TGA, HSA) for joint reviews and observes Project Orbis. The Swiss–EU MRA on GMP since 2002 means EU GMP certificates are recognised for inspection purposes.
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