Swissmedic reduces review times for generic medicinal products

Swissmedic has shortened the procedural time limits for applications for new authorisation of generic medicinal products. This change is part of the continuous development of the procedure under Art. 13 TPA (Changes to the guidance document Time limits for authorisation applications). The new time limits shorten the procedure for applications for authorisation of generic medicinal products to a total of 195 days. The new time limits took effect on 1 September 2025.

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Update to the Borderline Manual provides both guidance on product classification and insight into the Working Group thought process.