01.10.2025
Preliminary Decision Clarification Meeting for human medicinal products to be introduced
24.09.2025
The benefit-risk balance continues to remain positive
19.09.2025
The data dictionary for the swissdamed module UDI Devices has been published
01.09.2025
Change to the Guidance document Product information for human medicinal products
01.09.2025
Swissmedic has revised the guidance document Formal requirements accordingly, and this will enter into force on 1 September 2025
01.09.2025
Shortening of time limits for applications for new authorisation of medicinal products with known active substances without innovation under Art. 13 TPA
01.09.2025
Swissmedic requests marketing authorisation holders to review their medicinal products with genotoxic potential
27.08.2025
concerning the inclusion of the manufacturer for batch release
27.08.2025
With effect from 27.08.2025, the official publication website for product information texts approved by Swissmedic for veterinary medicinal products is changing
26.08.2025
Use of illegally marketed “slimming aids” may carry significant health risks
22.08.2025
Deadline of 18 December 2025 for comments
20.08.2025
Legal requirements not fulfilled
18.08.2025
International comparison of Swiss authorisation times
18.08.2025
With the new UDI Devices module, registering medical devices, including in vitro diagnostic medical devices, in the swissdamed database is now available
06.08.2025
Latest CIRS study rates Swissmedic's authorisation procedures for human medicinal products with new active substances as internationally competitive
23.07.2025
Entry into force of ICH GCP E6 (R3) and Appendix 1 on 15 August 2025
22.07.2025
The Memorandum of Understanding (MoU) lays the foundation for closer collaboration with the APVMA
16.07.2025
Swissmedic is issuing an urgent warning regarding slimming products and other supposedly natural products
09.07.2025
Bultavo 3 is now available as an authorised vaccine for sheep and cattle against variant (serotype) 3
08.07.2025
Third MAGHP authorisation: collaborative milestone for paediatric malaria treatment
08.07.2025
Deadline of 30 November 2025 for comments
08.07.2025
Informationen an die interessierten Verbände und Fachgesellschaften
08.07.2025
Deadline of 24 October 2025 for comments
01.07.2025
Updating of KPTPO annexes
01.07.2025
New identification of DHPCs with the "Red safety information" symbol
01.07.2025
Swissmedic publishes a new TI (Technical Interpretation) on the return of medicinal products
01.07.2025
Identification of officially ordered educational materials with the "Blue safety information" symbol and editorial revision
30.06.2025
Swissmedic supplements measures for the risk assessment of possible nitrosamine impurities in active substances and finished medicinal products
27.06.2025
Innovative therapies should reach patients faster
