Snapshot

The Procedure with prior notification (PPN) pathway has been developed by the Swissmedic of Switzerland.

This pathway can be used where The procedure with prior notification (PPN) allows companies that submit applications for the authorisation of human medicinal products with new active substances (New API) and preparations specified in Art. 12 para. 5 TPLO (human medicinal products with a known active substance that cannot be authorised via the simplified procedure) or for an additional indication (AI) to request Swissmedic to consider whether their application with a previously agreed timeframe can be processed within a timeframe that is 20 per cent shorter. In return, the applicant is willing to pay double the fee (Art. 7 FeeO-Swissmedic). However, in contrast to the fast-track authorisation procedure (FTP) in accordance with Art. 7 of the Therapeutic Products Ordinance (TPO), the PPN procedure does not confer upon the applicant any legal entitlement to a shorter procedure. Instead, the PPN procedure represents a special service offered by Swissmedic which, under certain conditions, makes it possible to reserve the resources required to carry out a normal authorisation procedure in advance, and thus to process the application more rapidly. The following conditions must be fulfilled before an authorisation application can be processed within the framework of a PPN: 1. The authorisation application must concern the first authorisation of a human medicinal product with a new active substance (New API), the first authorisation of a preparation specified in Art. 12 para. 5 TPLO, an additional indication (AI) for a human medicinal product that was originally authorised as a New API or as a preparation specified in Art. 12 para. 5 TPLO, an additional pharmaceutical form and/or an additional dosage recommendation; for these last two application types, however, the applications must be submitted together with the application for the first authorisation of the New API / preparation specified in Art. 12 para. 5 TPLO. 2. The clinical and preclinical studies should have been fully completed by the time the application is submitted. Once the application has been received, no further trial data, trial results or other documentation relevant to the evaluation may be submitted. If the indication requires long-term data, this data must be available at the time of submission. Interim analyses must be submitted together with the planned, complete and final study report in accordance with the study protocol, reflecting the status once the primary end point of the study has been reached. Full documentation must also be submitted. The submission must be based on up-to-date data and may not contain any immature or incomplete data. The subsequent submission at a later date of further documentation that is not explicitly requested is not possible within the framework of the ongoing procedure. Any results from foreign assessments available to the applicant, and in particular assessment reports from the EMA or the FDA, must be included with the submission. 3. Swissmedic must have the necessary human resources available in order to complete the assessment of the application within the required time and by the date foreseen..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA United States

- Within 30 CD, Swissmedic decides whether it will be possible to conduct the procedure requested under the prevailing circumstances on the date proposed by the company (+/- 2 calendar weeks). The outcome of this investigation is communicated to the applicant in writing. If it is not possible to carry out a PPN procedure on the date proposed by the applicant, Swissmedic considers alternative dates and suggests an alternative in its response. If the two parties are unable to agree on an alternative submission date, the applicant is informed that a PPN procedure cannot be carried out during the proposed timeframe. - If the company has been informed that a PPN procedure is possible within the timeframe it has proposed, it must inform Swissmedic in writing of the definitive submission date (+5 CD) for the PPN application (definitive prior notification) at the latest one month before this date. In this notification, the applicant should also state the submission format: eCTD or eDok. If, on this definitive submission date, particular developments in the human resources situation at Swissmedic make the performance of a PPN procedure unrealistic, the Agency will inform the applicant immediately and propose an alternative submission date for the PPN application or the submission of the authorisation application in the standard procedure. - If the date provided to the Agency for the submission (+5 CD) is not respected, or if the documentation submitted with the application has major shortcomings (which cannot be rectified by the applicant within 10 CD), with the result that the agreed schedule is unlikely to be observed, the submission will be accepted and processed as a normal authorisation application, i.e. outside the PPN procedure (subject to the normal flat fee specified in FeeO-Swissmedic and with no shortening of the processing period by 20%). The costs of examining the request and for the Presubmission Meeting will be billed on an hourly basis in accordance with Art. 4 para. 2 FeeO-Swissmedic.