Snapshot

The Fast-track authorisation procedure (FTP) pathway has been developed by the Swissmedic of Switzerland.

This pathway can be used where human medicinal products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The application should be submitted between 3 and 12 months before the authorisation application so that planning and procedural certainty can be guaranteed. The application for an FTP must be submitted to Swissmedic in writing by the applicant. The application must be substantiated scientifically and backed up by the required documentation. After the request for an FTP has been received, the documentation is formally checked within 5 calendar days. Swissmedic will decide within 30 days of completion of the formal checks of the application whether the criteria for an FTP under Art. 7 TPO are met. Depending on the result of the assessment of the Briefing Document and the submitted documentation, one of the following three processes, a), b) or c), will be applied: a) Criteria stipulated in Art. 7 TPO are fulfilled: If, after receiving the applicant's application, Swissmedic unconditionally agrees to review its authorisation application in the context of an FTP, and if the evaluation of the submitted documentation does not reveal any aspects requiring clarification, Swissmedic can dispense with the implementation of an AAA. In this case, Swissmedic will directly issue an official decision to approve the application for an FTP. The approval will be recorded in the decision minutes. These will be included as an integral part of the official decision. b) Criteria stipulated in Art. 7 TPO cannot be conclusively evaluated following the assessment of the Briefing Document: If the criteria for an FTP cannot be conclusively evaluated by Swissmedic following the assessment of the Briefing Document, Swissmedic will inform the applicant accordingly no later than 30 days after the completion of the formal check and advise the applicant of the date of an AAA. The applicant will be informed of the specific criterion that cannot yet be conclusively evaluated. The applicant will also be informed of the specific unresolved questions that will need to be clarified in connection with the AAA, or the specific aspects that must be fulfilled before the application for an FTP can be conclusively evaluated. The applicant will be informed of the final decision on the application for an FTP in connection with the AAA. c) Criteria stipulated in Art. 7 TPO are not fulfilled: If the evaluation of the submitted documentation reveals that the criteria stipulated in Art. 7 TPO are not fulfilled, Swissmedic will issue the applicant with a preliminary decision to reject the application. The applicant will be granted a time limit period of 10 days in which to submit a written statement or inform Swissmedic whether it would like to participate in an AAA. If the applicant decides not to take part in an AAA, after assessing the statement Swissmedic will inform the applicant of its final decision on the application for an FTP in the form of an official decision subject to appeal. If the implementation of an FTP is approved, the authorisation application can be submitted on the planned date stated on the decision minutes. Applicants must confirm to Swissmedic in writing the exact date on which they intend to submit the authorisation application, but at least one month before submitting the authorisation application. At the same time, applicants must indicate whether documentation on quality and preclinical aspects (ERA and/or modules 2.4/2.6/4) and an RMP are being submitted so that Swissmedic can recruit all the necessary specialist assessors for assessing the application. Swissmedic will check whether the required staff resources are available in the scheduled review period and confirm the date or, if applicable, propose an alternative date. The applicant may, if required, apply for a preliminary discussion of the dossier with Swissmedic at a pre-submission meeting. The aim of this Presubmission Meeting is to ensure that the authorisation application is complete upon submission and will not lead to any formal objections. Overall, the time from receipt of the application to reaching an official decision is 140 calendar days.