Pilot project on simultaneous national scientific advice starts 1 February 2020
Heard from FAMHP
January 21, 2020
The EU-Innovation Network announces a pilot project for simultaneous national scientific advice (SNSA) to strengthen early regulatory support for innovation. The pilot project kicks off with developing a best practice model starting 1 February 2020.
The pilot project will offer some interesting advantages for innovators as well as regulators.
- A coordinated approach to different national competent authorities (NCAs) for a defined set of questions and data packages in line with the procedure for national scientific advice (e.g. minutes and fees).
- An opportunity to discuss issues early on and simultaneously across selected member states.
- The possibility to achieve consolidated views and identify divergent opinions of participating NCAs.
- Support in order to meet timelines of the new clinical trial regulation.
- Early identification of issues of a critical scientific or regulatory kind that may require formal EU scientific advice from the European Medicines Agency (EMA).