General communications

12.05.2025

Public consultation for ICH Guideline Q1 “Stability Testing of Drug Substances and Drug Products” launched in Switzerland

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 appointed Head of Human Resources and Finance at Swissmedic

Jacqueline Rohrbach becomes the new Head of Human Resources and Finance, succeeding Barbara Schütz Baumgartner, who is retiring

01.05.2025

Risk assessment relating to nitrosamines in active substances and/or finished medicinal products

Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents

29.04.2025

Improved access to medicines – particularly paediatric medicinal products – during shortages

Federal Department of Home Affairs (FDHA) press release

03.04.2025

Swissmedic joins the Management Committee of the IMDRF

Swissmedic's appointment to the Management Committee of the IMDRF strengthens international cooperation and supports efficient regulation in Switzerland

01.04.2025

Expansion of the Swissmedic position paper on real world evidence

Swissmedic is expanding its position paper on real world evidence (RWE) with an overview of relevant international guidelines and publications

01.04.2025

Changes to the Guidance document Meetings for applicants for authorisation procedures

Optimisation of meetings for applicants for authorisation procedures

01.04.2025

Changes to the Guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

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

Falsified medicinal products entering the supply chain: Swissmedic intensifies controls on international trade with suppliers from non-EU countries

Increased vigilance in international trading in medicinal products – Swissmedic responds to cases of falsified products with stricter controls

21.03.2025

Launch Strategic Plan Access Consortium 2025 - 2028

Access Consortium: Updated strategic plan outlines approach to regulatory collaboration

17.03.2025

Newly appointed Swissmedic Expert Committees start work

The Swissmedic Medicines Expert Committees (SMEC) have begun the 2025–2028 period of office with a new line-up

07.03.2025

Overview of international authorisation procedures

International collaboration in authorisation procedures

01.03.2025

Changes to the Guidance document Authorisation of herbal medicinal products

Content-related clarifications, additions and restructuring of the entire Guidance document

28.02.2025

Authorisations of human medicinal products with a new active substance and additional indications 2024

46 human medicinal products with new active substances authorised

24.02.2025

Adoption of ICH GCP Guideline E6(R3)

Adoption of ICH GCP E6 (R3) and Appendix 1 in summer 2025

14.02.2025

Illegal imports of medicinal products in 2024: continuing trend in high-dose erectile dysfunction products

Number of illegally imported medicinal products falls slightly

07.02.2025

Bluetongue: authorisation of the BTVPUR vaccine

Swissmedic authorises the BTVPUR vaccine for the protection of sheep and cattle against the bluetongue serotypes 1, 2, 4 and 8

31.01.2025

Refined interpretation of the Mutual Recognition Agreement (MRA) between Canada and Switzerland

Swissmedic and Health Canada agreed to expand their approach regarding the implementation of the current MRA

28.01.2025

Supposedly herbal products

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

16.01.2025

Legal mandate: surveillance of reporting and advertising for medicinal products

In the event of suspected infringements of the Medicinal Products Advertising Ordinance, Swissmedic is obliged to take measures

01.01.2025

Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs) and the Medical Devices Ordinance

The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025

01.01.2025

Optimisation of labelling phase for human medicinal products

Swissmedic is optimising the labelling phase: text review letters should be avoided where possible and the Swissmedic time limits are being shortened

01.01.2025

Changes to the form Information for application Art. 13 TPA

The previous form Information for application Art. 13 TPA has been divided into two forms: one specifically for veterinary medicinal products and the other for human medicinal products

01.01.2025

Election of the members of the Swissmedic Medicines Expert Committees

Election and re-election of our external experts for the new period of office 2025–2028

01.01.2025

Changes to the Guidance document Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)

Market surveillance measures based on safety signals or quality defects in the original medicinal product must also be implemented for parallel imported medicinal products

01.01.2025

Amendment of the rules of the Swissmedic Medicines Expert Committees

Maximum number of ordinary VMEC members increased from seven to nine

01.01.2025

Changes to the Full declaration form

Listing the full qualitative composition of aromatic substances in human and veterinary medicinal products is no longer mandatory

Last modification 22.11.2022

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