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


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


Benchmarking 2020 – Comparison of Swiss approval times for human medicines with the EU and the USA and analysis of national authorisation procedures

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


Modification of various documents relating to authorisation

ZL000_00_024e_WL / ZL101_00_007e_WL


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


Optimisation of labelling phase for human medicinal products

Avoiding text review rounds


Submission of DMF updates

Type II variations now possible


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


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