Swissmedic, the Swiss regulatory authority for therapeutic products, has introduced updates to its guidance documents for the Fast-track Authorization Procedure (FTP) and Temporary Authorization (Temp. Auth.) for human medicinal products. These adjustments aim to streamline and optimize application processes, providing pharmaceutical companies with clearer guidelines and expedited pathways to bring critical medicines to market more quickly.
Key Changes in Authorization Processes
Optimized Application Process
The updated guidelines refine the application process for fast-track and temporary authorizations, making it more efficient for applicants. In cases where the submitted documents for FTP or Temp. Auth./Temp. AI (Temporary Additional Indication) does not fully meet the criteria upon initial review, Swissmedic typically schedules an Accelerated Application Hearing (AAA). Now, Swissmedic has the option to waive this hearing if supplementary documentation provided by the applicant adequately meets all requirements for the requested authorization.
Outcome: If all criteria are met upon reviewing the additional documents, Swissmedic will proceed directly to issue a formal decision approving the FTP or Temp. Auth./Temp. AI, reducing procedural steps and accelerating access to authorization.
Clarified Submission Date for Authorization
With the approval of the FTP or Temp. Auth./Temp. AI procedure, applicants can now follow a specific submission timeline. The updated process provides a clear submission date for the authorization application based on the decision minutes. However, if an applicant wishes to submit the authorization request earlier than the indicated date, they may now contact Swissmedic to discuss the feasibility of early submission.
Updated Guidance Documents in Effect
To reflect these changes, Swissmedic has revised its guidance documents on the Fast-track Authorization Procedure and Temporary Authorization, which officially came into effect on 15 October 2024. These updates are part of Swissmedic’s commitment to balancing rapid access to essential therapies with robust safety and efficacy standards.
By implementing these optimizations, Swissmedic aims to support pharmaceutical companies in navigating the authorization process more effectively, ultimately benefiting public health by enabling quicker access to innovative treatments.
Source: Swissmedic
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