Swissmedic launches the public consultation on Guideline Q1 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 30 July 2025 for comments
Swissmedic establishes the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents
Swissmedic's appointment to the Management Committee of the IMDRF strengthens international cooperation and supports efficient regulation in Switzerland
Clarification of the submission date for an authorisation application for a fast-track authorisation procedure (FTP) or the implementation of temporary authorisation (temp.auth./temp.AI)
The previous form Information for application Art. 13 TPA has been divided into two forms: one specifically for veterinary medicinal products and the other for human medicinal products
Market surveillance measures based on safety signals or quality defects in the original medicinal product must also be implemented for parallel imported medicinal products
