Information

03.07.2020

A study confirms Swissmedic’s international Competitiveness

In an international comparison of the processing time for scientific assessments, Swissmedic is on a par with the fastest authorities

01.07.2020

Optimisation of labelling phase for human medicinal products

Avoiding text review rounds

01.07.2020

Submission of DMF updates

Type II variations now possible

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