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

Target time assessment is New application under the procedure with prior notification (Ann. 1 no. I no. 1. FeeO-SMC): 1. Swissmedic formal control = 10 calendar days; 2. Applicant correction of documents subject to formal objection = 10 calendar days; 3. Swissmedic Eval. I = 100 calendar days; 4. Applicant reply to LoQ = 90 calendar days; 5. Swissmedic Eval. II = 90 calendar days; 6. Applicant reply to PD = 60 calendar days. In the event of a PD rejection, companies have 30 CD to respond to the PD. 7. Swissmedic eval. of reply to PD = 64 calendar days. Total applicant time = 160 calendar days. Total Swissmedic time = 264 calendar days. Total Swissmedic + applicant time = 464 calendar days. .