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.

Logo FAMHP2.jpgThe pilot project will offer some interesting advantages for innovators as well as regulators.

  • 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).

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