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General communications

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

09.07.2025

Swissmedic authorises vaccine to control bluetongue serotype 3

Bultavo 3 is now available as an authorised vaccine for sheep and cattle against variant (serotype) 3

08.07.2025

Swissmedic grants authorisation for a paediatric antimalarial under the Marketing Authorisation for Global Health Products (MAGHP) procedure

Third MAGHP authorisation: collaborative milestone for paediatric malaria treatment

08.07.2025

Public consultation on ICH Guideline E20 “Adaptive Designs for Clinical Trials” launched in Switzerland

Deadline of 30 November 2025 for comments

08.07.2025

Schweizerische Gute Praxis zur Aufbereitung von Medizinprodukten in ambulanten Gesundheitseinrichtungen (GPA-ambulant)

Informationen an die interessierten Verbände und Fachgesellschaften

08.07.2025

Public consultation on ICH Guideline M4Q(R2) “Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality” launched in Switzerland

Deadline of 24 October 2025 for comments

01.07.2025

KPTPO: Updating of annexes 6, 7 and 10

Updating of KPTPO annexes

01.07.2025

Adaptation of guidance document "DHPC HMP"

New identification of DHPCs with the "Red safety information" symbol

01.07.2025

New technical interpretation: I-SMI.TI.28 Returns of medicinal products

Swissmedic publishes a new TI (Technical Interpretation) on the return of medicinal products

01.07.2025

Update to the guidance document “RMP ICH E2E Information for submission HMP”

Identification of officially ordered educational materials with the "Blue safety information" symbol and editorial revision

30.06.2025

Nitrosamine impurities in medicinal products: updated requirements for risk assessments, data submission and parallel import products

Swissmedic supplements measures for the risk assessment of possible nitrosamine impurities in active substances and finished medicinal products

30.06.2025

Einführung einer einheitlichen Kennzeichnung von Mitteilungen zur Arzneimittelsicherheit (DHPC) und behördlich angeordnetem Informationsmaterial

ab Juli 2025

27.06.2025

Faster processing of applications for clinical trials

Innovative therapies should reach patients faster

25.06.2025

Vincenza Trivigno appointed Executive Director of the Swiss Agency for Therapeutic Products

Federal Department of Home Affairs (FDHA) press release

23.06.2025

Veterinary medicinal products supply report published

Security of supply for veterinary medicinal products: Swissmedic and FSVO present solutions

18.06.2025

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

13.06.2025

Federal Council approves report in response to a postulate on the monitoring of drug safety

Federal Department of Home Affairs (FDHA) press release

06.06.2025

Swissmedic publishes its Annual Report and financial statements for 2024

Federal Council approves Swissmedic's Annual Report on its activities for the year 2024

05.06.2025

Public consultation on ICH Guideline E21 “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” launched in Switzerland

Deadline of 15 September 2025 for comments

04.06.2025

"Swissmedic 4.0" digital initiative concludes

A look back and a look ahead

01.06.2025

Swissmedic position on conjugated pneumococcal vaccines

Swissmedic updates requirements for authorisation applications for conjugated pneumococcal vaccines

01.06.2025

Modification of the guidance document Authorisation of immunological veterinary medicinal products in the event of an epizootic outbreak

New section on authorisation in exceptional circumstances in accordance with Art. 25 of EU Regulation 2019/6

01.06.2025

Changes to the guidance document Time limits for authorisation applications

Time limits shortened for additional indications for Orbis type A and fast-track Orbis type B

28.05.2025

Amendment to the guidance document on GMP compliance by foreign manufacturers

Clarification of the requirements for the submission of audit reports and risk assessments

26.05.2025

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

New areas of harmonisation adopted; significant advancement of ongoing activities

19.05.2025

Swissmedic and Swedish partner authority agree on closer collaboration in therapeutic products field

Swissmedic and the Swedish Medical Products Agency (MPA) sign agreement on information exchange

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

Last modification 22.11.2022

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