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).
The opportunity to discuss the experiences and lessons learned from completed SNSA cases at the EU-Innovation Network and potentially relevant working groups and scientific committees of EMA. Resulting in knowledge sharing within the regulatory network, enhanced preparedness for incoming innovation and reflection on regulatory challenges.
The pilot project starts 1 February 2020. The main objective is developing a best practice model with as many different NCAs pairs as possible (two NCAs can be proposed by the applicant per SNSA request submitted in 2020). If the pilot project gets a positive evaluation at the end of 2020, it may be extended to more than two NCAs per SNSA request after 2020.
Soon, announcements of the SNSA pilot project containing detailed information will be made on the websites of the Heads of Medicine Agencies (HMA), EMA and participating NCAs.