The process for applying for the implementation of an FTP has been optimised. Differing processes will be employed in future based on the result of the assessment of the documentation submitted with the application for the implementation of an FTP.
In particular, Swissmedic will now issue a preliminary decision to reject the application for the implementation of an FTP if the assessment reveals that the criteria specified in Art. 7 TPO are not met. The applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA).
Additionally, criterion c – A high therapeutic benefit is expected from using this new medicinal product – has been explained in more detail.
The Guidance document Fast-track authorisation procedure has been amended accordingly and will apply from 15 January 2024.