Information

01.10.2020

Swissmedic extends the MAGHP procedure

The new Light procedure builds on the established MAGHP procedure, but is explicitly applicable to applications for the fast-track authorisation procedure and for temporary authorisation

18.09.2020

Authorisation of medicinal products for the prevention and treatment of COVID-19

Publication of new guidance document on procedures for authorising medicinal products during a pandemic

18.08.2020

Swiss approval times for human medicines: seventh benchmarking study

Swissmedic compared with the EMA and the FDA and analysis of the national authorisation procedures

01.08.2020

Modification of various documents relating to authorisation

ZL000_00_024e_WL / ZL101_00_007e_WL

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