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

15.09.2020

Modification of the Guidance document Authorisation in accordance with Art. 14para. 1 abis-quater TPA HMV4

ZL000_00_022e_WL

01.09.2020

Changes to the guidance document MAGHP Procedure

ZL000_00_047e_WL

18.08.2020

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

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

New ruling concerning extensions granted for authorisation applications for human medicinal products

Swissmedic is changing its practice

Results 1 - 15 of 88

Supplementary information

Allocation of ATC code for human medicinal products (excl. CHM) to Case Management (XLS, 265 kB, 01.01.2021)

Allocation of CHM to Case Management (XLS, 2 MB, 30.09.2020)

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