The process for applying for the implementation of a fast-track authorisation procedure (FTP) or the implementation of temporary authorisation / temporary additional indication (temp.auth. / temp.AI) has been optimised.
If the criteria for an FTP or a temp.auth. / temp.AI cannot be conclusively evaluated following the assessment of the submitted documents by Swissmedic, an Accelerated Application HeAring (AAA) usually takes place.
Swissmedic can now dispense with the implementation of an AAA if the additional documents submitted by the applicant for the scheduled AAA show that all of the criteria for the requested authorisation procedure are fulfilled. In this case, Swissmedic will issue an official decision to approve the request for the implementation of an FTP or temp.auth. / temp.AI.
The submission date for the authorisation application has also been clarified. Provided the application procedure for the implementation of an FTP or temp.auth. / temp.AI is approved, the applicant can submit the authorisation application on the date stated on the decision minutes. If, after receiving the positive ruling on the requested authorisation procedure, the applicant would like to submit the authorisation application on an earlier date, the applicant can now contact Swissmedic in order to check whether earlier submission is possible.
Swissmedic has updated the guidance documents Fast-track authorisation procedure / Temporary authorisation for human medicinal products accordingly.
These documents will take effect on 15 October 2024.