Information

27.05.2020

Whitsun 2020: Planned interruption to Swissmedic eGov services due to extensive maintenance work at FOITT Data Center

Network changeover by the Federal Office of Information Technology, Systems and Telecommunication (FOITT)

26.05.2020

Swissmedic approves first new active substance as part of Project Orbis

Tucatinib for the treatment of a particularly aggressive type of breast cancer reviewed in four months

13.05.2020

Swissmedic authorises a medicinal product under the Marketing Authorisation for Global Health Products (MAGHP) procedure for the first time

This approval in Switzerland paves the way for the approval and introduction in low- and middle-income countries

21.04.2020

Evaluation of potential nitrosamines in connection with new authorisations

The new requirements enter into force immediately

26.03.2020

Election of the Swissmedic Medicines Expert Committees (SMEC) for the 2021-2024 term of office

Independent experts as an additional quality-assurance element in the authorisation process

25.02.2020

International cooperation on therapeutic products

Swissmedic authorises a new active substance (NAS) under the ACSS Consortium initiative for the first time

01.02.2020

Guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 updated

The new version of the guidance document enters into force on 1 February 2020.

20.01.2020

Notes on using Swissmedic templates for Information for healthcare professionals and Patient information

There are two versions of Swissmedic's templates for Information for healthcare professionals and Patient information for human medicinal products

15.01.2020

Updating of guidance document on authorisation of human medicinal products under Art. 13 TPA HMV4

Changed procedure for "Justified cases" pursuant to Art. 18 para. 2 TPO