15. October 2024 – Swissmedic has announced that the updated guidance documents for the Fast-Track Authorization Procedure (FTP, document link) and the Temporary Authorization (temp.auth.) as well as the Temporary Additional Indication (temp.AI, document link) came into effect on 15 October 2024. These changes aim to optimize the application process for applicants, particularly in cases where the submitted documentation is insufficient for a conclusive evaluation of the authorization criteria. Typically, an Accelerated Application Hearing (AAH) is conducted; however, Swissmedic now has the option to waive this procedure if the supplemental documents submitted by the applicant for the scheduled AAH demonstrate that all criteria for the requested authorization procedure are fulfilled.

Furthermore, the submission date for the authorization application has been clarified. Provided that the application procedure for the FTP or temp.auth. / temp.AI is approved, the applicant may submit the authorization application on the date specified in the decision minutes. If, after receiving a positive ruling on the requested authorization procedure, applicants wish to submit the authorization application on an earlier date, they may now contact Swissmedic to ascertain whether an earlier submission is possible.

For more information, see here.