Information on changes to the guidance document (formerly Information sheet) on the Fast-track authorisation procedure

01.10.2017 - The Fast-track authorisation procedure (FTP) guidance document has been modified in form and content as follows:

 

  • The Information sheet has been formally transposed into a guidance document.
  • The criteria for the fast-track procedure are specified in greater detail (section 6.1)
    • The target population on which the application is based must have been investigated in correspondingly designed clinical studies. The requested indication should be defined according to the implemented study and should not be framed in broader terms. Moreover, a fast-track procedure for a much more broadly framed indication should not be requested for a small subgroup of the investigated target population unless an extrapolation is scientifically justified.
    • The target population according to the requested indication should include patients with the corresponding established and clearly defined disease entity.
  • The formal aspects and the documentation required for the FTP application are specified in greater detail (section 6.2)
    • A tabular listing with a brief description of the pivotal studies for the FTP application is now required. The table from CTD module 5.1 "Table of All Clinical Studies" can be used as a template for this listing.
  • The period for reviewing the response to the preliminary decision on the FTP application is specified (section 6.3)
    • A time limit of 20–90 CD, depending on the respective review workload and the volume of submitted documentation, is usually required before the preliminary decision can be made by Swissmedic. The actual time limit can be viewed 10 days after receipt in the eGov Portal (the internet-based eGov service for electronic legal transactions and for information and data sharing).
      The overview of Time limits for authorisation applications has been amended accordingly.
  • New section 6.4: Combination of an FTP application with a request for a procedure with prior notification (PPN).

    • This section has been newly added in line with the Procedure with prior notification guidance document. It is now possible to submit a request for the implementation of a PPN (see Procedure with prior notification guidance document) at the same time as an FTP application. This means that, if the FTP application were to be rejected, the applicant does not need to wait for this rejection before submitting a request to implement a PPN, but can confirm the possible implementation of the desired PPN as a statement in response to the preliminary decision.

    • If the request to switch to the PPN is received together with the statement in response to the FTP application, this will be processed as a standalone new request for the implementation of a PPN with the corresponding time limits.