Snapshot

The Temporary authorisation for human medicinal products pathway has been developed by the of Switzerland.

This pathway can be used where Temporary authorisation is possible in the following circumstances (provided the criteria per Art. 9a TPA in conjunction with Art. 18 TPLO are fulfilled): (i) New authorisation of human medicinal products with new active substance (NAS); (ii) New authorisation of human medicinal products with known active substance (KAS) if an indication not previously authorised is requested (KAS with innovation); (iii) Additional indication for human medicinal products..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

After the request for a temp.auth. or temp.AI has been received, the documentation is formally checked within 5 calendar days. Swissmedic will decide, no later than 30 days after completion of the formal checks, whether the 5 criteria for a temp.auth. or temp.AI 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) Temporary authorization criteria are fulfilled: If, after receiving the applicant's request, Swissmedic unconditionally agrees to review its authorisation application in the context of a temp.auth. or temp.AI, 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 request for a temp.auth. or temp.AI. The approval will be recorded in the decision minutes. These will be included as an integral part of the official decision. b) Temporary authorization criteria cannot be conclusively evaluated following the assessment of the Briefing Document: If the criteria for a temp.auth. or temp.AI 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 control 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 request for a temp.auth. or temp.AI can be conclusively evaluated. The applicant will be informed of the final decision on the request for a temp.auth. or temp.AI in connection with the AAA. c) Temporary authorization criteria stipulated in Art. 18 TPLO are not fulfilled: If the evaluation of the submitted documentation reveals that the criteria stipulated in Art. 18 TPLO are not fulfilled, Swissmedic will issue the applicant with a preliminary decision to reject the request. 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 request for a temp.auth. or temp.AI in the form of an official decision subject to appeal. In summary, the temp.auth application process takes 140 calendar days from receipt of application by Swissmedic to the official decision being made. For the ex-officio temp.auth, time from receipt of application by Swissmedic to preliminary decision: approval (temp.auth. “subject to conditions”) with partial rejection takes 240 calendar days. Pre-Submission Meeting: If the request for temp.auth or temp.AI has been approved, a Presubmission Meeting can be held if required between one and two months before the application for temp.auth or temp.AI is submitted. The aim of the meeting is to establish whether all the documentation required to process the application is available. In particular, the following formal aspects of the authorisation application to be submitted will be considered: (i) Index of scientific and administrative documentation; (ii) Any unresolved questions concerning incomplete clinical documentation and the times at which it will be submitted. The definitive submission date is established at the Presubmission Meeting.