From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation
From 1 September 2024, Swissmedic is accepting SEND data sets for applications for new authorisation for human medicinal products with new active substances
Swissmedic launches the public consultation on Guideline M14 “Bioequivalence for Immediate-Release Solid Oral Dosage Forms General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines” of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 30 August 2024 for comments
Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities
As there will no longer be any legal basis for doing so, Swissmedic will cease granting exceptions with regard to the authorisation and importing of medicinal products for the treatment or prevention of COVID-19
