16 October 2017 - On 1 October 2017, the Swiss Agency for therapeutic products updated its guidance document concerning the fast-track authorisation procedure. The modified guidance document replaced the formerly Information sheet on the fast-track authorisation procedure.

For the authorisation of a medicinal product for human use in Switzerland, a fast-track procedure may be conducted provided all of the criteria provided in Article 5 of the Ordinance on Medicinal Products are fulfilled. Contrary to the normal procedure, a request for a fast-track procedure must be submitted to SwissMedic in advance and be approved.

SwissMedic’s guidance document is intended to clarify the specific requirements that must be fulfilled in order to assess fast-track authorisation applications as quickly as possible.

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