Swissmedic: New Application Procedure for an FTP / Temporary Authorisation of Human Medicinal Products

18 dicembre 2020 – The existing application procedures for fast-track (FTP) and temporary authorisations (temp.auth.) are to be replaced by the Accelerated Application Hearing (AAA) meeting with the applicant. The introduction of the AAA allows Swissmedic to discuss planned FTP and temp.auth. procedures with the applicant at an early stage. The AAA can take place between 2 and 12 months before the submission of the authorisation application. During the hearing, Swissmedic discusses with the applicant whether a procedure for an FTP or temporary authorisation is possible on the basis of the scientific documentation submitted with the application for an AAA.

For further information, see here.