[co-author: Eftychia Sideri]

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly Information sheet on the FTP.

Background information

For the authorisation of a medicinal product for human use in Switzerland, a fast-track procedure may be conducted provided all of the criteria provided in Article 5 of the Ordinance on Medicinal Products (VAM, SR 812.212.21) are fulfilled. Contrary to the normal procedure, a request for a fast-track procedure must be submitted to Swissmedic in advance and be approved.

Swissmedic’s guidance document is intended to clarify the specific requirements that must be fulfilled in order to assess fast-track authorisation applications as quickly as possible.

Swissmedic’s Changes

The guidance document provides more clarity concerning the conditions necessary to evaluate a FTP. According to the guidance, the FTP can be initiated when there is a promising therapy for a severe, debilitating or life-threatening disease. Swissmedic has updated the criteria for a “promising therapy” by adding that the target population on which the application is based must have been investigated in correspondingly designed clinical studies. Additionally, the requested indication should be defined according to the implemented study and should not be framed in broad terms. According to the guidance, FTPs for broadly frame indications cannot be requested for a small subgroup of the investigated target population unless an extrapolation is scientifically justified. The guidance clarifies that the target population according to the requested indication should include patients with the corresponding established and clearly defined disease.

In addition, the guidance document provides greater specification of the formal aspects and the documentation to be submitted in relation to a request for a FTP. Swissmedic provides in the updated guidance document that an overview of the data scheduled for the future authorisation application should also be submitted. This overview should be in the form of a tabular listing with a brief description of the pivotal studies, the number of patients for efficacy and safety results and stating whether interim or final study reports are involved. Swissmedic advises that the table from CTD module 5.1 “Table of All Clinical Studies” can be a useful tool for the FTP applicants.

The guidance document specifies the period for reviewing the response regarding the preliminary decision in the framework of the FTP. The guidance provides that the applicant has the option to take a stance regarding the preliminary decision within 30 days. A time limit of 20–90 CD, depending on the respective review workload and the volume of submitted documentation, is normally required before the preliminary decision can be made by Swissmedic.

Swissmedic has added a new section (Section 6.4) to the updated guidance document concerning the combination of an FTP application with a request for the procedure with prior notification (“PPN”). According to the guidance document, there is a possibility to submit at the same time an FTP application and a request for the implementation of a PPN. All the required information and documentation must be submitted concurrently.