International authorisation procedures

In addition to standard authorisation procedures, Swissmedic offers or participates in a number of international authorisation procedures with the aim of accelerating access to medicines for patients in Switzerland and collaborating countries.

Collaboration with other national regulatory authorities allows Swissmedic to strengthen its international collaboration, to share knowledge and expertise across jurisdictions and to promote regulatory convergence.

Depending on the procedure, applications are simultaneously or subsequently submitted to Swissmedic and collaborating authorities, and are assessed across multiple countries.

The scientific dialogue facilitates the independent decision-making process.

In all procedures, Swissmedic makes its own sovereign decision on the applications based on its quality, safety and efficacy standards.