06.06.2025
Federal Council approves Swissmedic's Annual Report on its activities for the year 2024
05.06.2025
Deadline of 15 September 2025 for comments
04.06.2025
A look back and a look ahead
01.06.2025
Swissmedic updates requirements for authorisation applications for conjugated pneumococcal vaccines
01.06.2025
New section on authorisation in exceptional circumstances in accordance with Art. 25 of EU Regulation 2019/6
01.06.2025
Time limits shortened for additional indications for Orbis type A and fast-track Orbis type B
01.06.2025
Information on the RMP update
28.05.2025
Clarification of the requirements for the submission of audit reports and risk assessments
26.05.2025
New areas of harmonisation adopted; significant advancement of ongoing activities
19.05.2025
Swissmedic and the Swedish Medical Products Agency (MPA) sign agreement on information exchange
12.05.2025
Swissmedic launches the public consultation on Guideline Q1 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 30 July 2025 for comments
01.05.2025
Jacqueline Rohrbach becomes the new Head of Human Resources and Finance, succeeding Barbara Schütz Baumgartner, who is retiring
01.05.2025
Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents
01.05.2025
Clarifications and changes
29.04.2025
Federal Department of Home Affairs (FDHA) press release
22.04.2025
Deadline of 09 July 2025 for comments
03.04.2025
Swissmedic's appointment to the Management Committee of the IMDRF strengthens international cooperation and supports efficient regulation in Switzerland
01.04.2025
Swissmedic is expanding its position paper on real world evidence (RWE) with an overview of relevant international guidelines and publications
01.04.2025
Optimisation of meetings for applicants for authorisation procedures
01.04.2025
Clarification of the submission date for an authorisation application for a fast-track authorisation procedure (FTP) or the implementation of temporary authorisation (temp.auth./temp.AI)
27.03.2025
Increased vigilance in international trading in medicinal products – Swissmedic responds to cases of falsified products with stricter controls
21.03.2025
Access Consortium: Updated strategic plan outlines approach to regulatory collaboration
17.03.2025
The Swissmedic Medicines Expert Committees (SMEC) have begun the 2025–2028 period of office with a new line-up
07.03.2025
International collaboration in authorisation procedures
01.03.2025
Content-related clarifications, additions and restructuring of the entire Guidance document
28.02.2025
46 human medicinal products with new active substances authorised
24.02.2025
Adoption of ICH GCP E6 (R3) and Appendix 1 in summer 2025
14.02.2025
Number of illegally imported medicinal products falls slightly
07.02.2025
Swissmedic authorises the BTVPUR vaccine for the protection of sheep and cattle against the bluetongue serotypes 1, 2, 4 and 8
