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null The SNSA pilot starts

The SNSA pilot starts

4.2.2020

The EU Innovation Network has started a pilot project to gain experience on simultaneous national scientific advice (SNSA).

To promote pharmaceutical development, national competent authorities (NCAs) have provided scientific advice both centrally at the EU level and nationally. National scientific advice has often been sought from more than one Member State. The pilot project now started will look at combining the scientific advice provided by two different Member States into a single meeting.

In the new pilot project, the applicant submits sufficient background information and the same detailed questions to both NCAs providing scientific advice. One of the two will act as the coordinating Member State that takes care of liaisons and arrangements and with which the scientific advice meeting will be arranged face-to-face. The other Member State providing scientific advice will participate in the meeting over remote connections. Both NCAs will evaluate the material and provide advice independently. Minutes will be drafted of the joint meeting by the applicant seeking scientific advice that can then be commented by each NCA.

This uniform procedure provides the applicant with an opportunity to utilise the broader expertise of different NCAs to obtain answers to the previously made questions. The procedure follows many of the forms familiar from the national scientific advice process, with data packages, minutes and fees, which will be charged separately by both NCAs.

This provides an opportunity to discuss matters earlier and simultaneously with the NCAs chosen by the applicant. This, in turn, makes it possible to identify shared views and divergent opinions. For the NCAs, this provides capabilities to handle new innovations and an opportunity to identify development needs in their own operations.

The countries participating in the pilot are Austria, Belgium, Czech Republic, Finland, Germany, Hungary, Italy, Norway, Poland and Spain.

Further information is available on the EMA website.