General communications

12.12.2025

Two new members appointed to Swissmedic Agency Council

These appointments are part of the process of re-electing the entire Agency Council for the 2026–2029 period

05.12.2025

Aufsichtsabgabe 2025 – Selbstdeklaration

Eingabefrist: 23. Januar 2026

01.12.2025

Meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The Assembly of the International Council for Harmonisation met in person on 18-19 November 2025 in Singapore

01.12.2025

Changes to the Guidance document Packaging for human medicinal products

A printed package leaflet can be dispensed with in future for medicinal products for use exclusively by healthcare professionals

27.11.2025

swissdamed Playground

The playground for the swissdamed UDI Devices module is now available

06.11.2025

Annual report on inspections of clinical trials as part of Good Clinical Practice (GCP)

In human clinical trials, compliance with GCP standards is crucial

05.11.2025

Use of titanium dioxide in medicinal products

Titanium dioxide continues to be permitted as an excipient in medicinal products in Switzerland

03.11.2025

Simap: Swissmedic invites tenders for a Document and Records Management System (DRMS)

So that Swissmedic can efficiently process its business-relevant documents in the long term, it is launching an invitation for tenders to supply a records management system

01.11.2025

Changes to the guidance document Authorisation PSUR Signal Management TAM

References added to annual reports from the signal management process

01.11.2025

Modification of the information sheet Drug Safety Reporting Duties in Switzerland

Update of contact details and document links

01.10.2025

Changes to the Guidance document Meetings for applicants for authorisation procedures

Preliminary Decision Clarification Meeting for human medicinal products to be introduced

24.09.2025

Statement on the use of medicines containing paracetamol during pregnancy

The benefit-risk balance continues to remain positive

19.09.2025

swissdamed technical documents

The data dictionary for the swissdamed module UDI Devices has been published

01.09.2025

Disposal information to be added to Patient information

Change to the Guidance document Product information for human medicinal products

01.09.2025

Revision of the guidance document Formal requirements

Swissmedic has revised the guidance document Formal requirements accordingly, and this will enter into force on 1 September 2025

01.09.2025

Changes to the guidance document Time limits for authorisation applications

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

Duration of contraception following the end of treatment with medicinal products with genotoxic potential

Swissmedic requests marketing authorisation holders to review their medicinal products with genotoxic potential

27.08.2025

New publication website for veterinary medicinal product information and new practice

concerning the inclusion of the manufacturer for batch release

27.08.2025

New official publication website for product information approved by Swissmedic for veterinary medicinal products

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

Swissmedic issues warning against falsified and misleading “GLP-1” weight loss products

Use of illegally marketed “slimming aids” may carry significant health risks

20.08.2025

Hospital Inspections Annual Report 2024

Legal requirements not fulfilled

18.08.2025

Benchmarking study 2024

International comparison of Swiss authorisation times

18.08.2025

New in swissdamed: Medical device registration now available

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

International study on authorisation times confirms Swissmedic's competitiveness

Latest CIRS study rates Swissmedic's authorisation procedures for human medicinal products with new active substances as internationally competitive

23.07.2025

Adoption of ICH GCP Guideline E6(R3)

Entry into force of ICH GCP E6 (R3) and Appendix 1 on 15 August 2025

22.07.2025

Swissmedic and the Australian Pesticides and Veterinary Medicines Authority agree on closer cooperation in the area of veterinary medicines

The Memorandum of Understanding (MoU) lays the foundation for closer collaboration with the APVMA

16.07.2025

Supposedly herbal products

Swissmedic is issuing an urgent warning regarding slimming products and other supposedly natural products

Last modification 22.11.2022

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