24.04.2024
Swiss Agency for Therapeutic Products supports creation of optimum framework conditions for Swiss biotech industry
18.04.2024
Grant agreement signed to continue supporting regulatory authorities in low and middle-income countries for a further three years
26.03.2024
"Lemon Bottle" lipolysis solution is not approved for distribution in Switzerland and must not be sold or used
06.03.2024
Swissmedic’s preliminary recommendation
04.03.2024
Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
12.02.2024
41 human medicinal products with new active substances authorised
08.02.2024
Number of illegally imported medicinal products remains at the same level
01.02.2024
Prior notification of a new application with a new active substance enables Swissmedic to plan resources early on and supports efficient processing of applications
30.01.2024
Risk assessment measures for nitrosamine drug substance-related impurities (NDSRI) further specified
15.01.2024
Clarification of the term "equivalent medicinal product" and timing of criteria assessment for temporary authorisation
15.01.2024
Optimisation of the application procedure for the implementation of a fast-track authorisation procedure (FTP)
15.01.2024
The guidance document Authorisation of human medicinal products TPA and the form Information for application Art. 13 TPA have been revised
15.01.2024
Publication of new guidance document on procedures for authorising immunological veterinary medicinal products in the event of an epizootic outbreak
15.01.2024
Explanations regarding dispensing category classification and clarification of the requirements for the application documentation for authorisations according to Art. 14 para. 1 letter abis-quater TPA
10.01.2024
Swissmedic is efficient, competitive and fit for purpose according to SFAO
03.01.2024
Swissmedic sets the course for the future
01.01.2024
Simplification of parallel imports of human medicinal products already authorised in Switzerland
18.12.2023
The manufacturer Novavax is no longer pursuing marketing authorisation for its COVID-19 vaccine in Switzerland
07.12.2023
The new guidance document and the form for submitting signals for veterinary medicinal products are now available
01.12.2023
Eingabefrist: 22. Januar 2024
27.11.2023
Self-prescribed use of sleep hormones or supposed "anti-ageing" products can be harmful to health
13.11.2023
Excellent Progress made on ICH harmonisation activities in Prague, Czech Republic
06.11.2023
In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs)
01.11.2023
Swissmedic, already considered as stringent regulatory authority, is now listed as a WHO Listed Authority (WLA) and recognised in all regulatory functions
01.11.2023
When the changes entered into force on 1 November 2023, Swissmedic updated its website in this regard and published implementation guides
31.10.2023
Authorities checked shipments of medicinal products worldwide from criminal online sales
09.10.2023
The Regional Council in Freiburg im Breisgau, Germany, has warned against the use of counterfeit Ozempic® pens
09.10.2023
Ten individual substances and one substance group added to the Narcotics List