EU Pilot:  2 Member States Simultaneous National Scientific Advice (SNSA) Procedure starts 1st February

Currently in the EU, companies seeking scientific and/or regulatory advice for a medicinal product have two options:

  1. Individual scientific advice sought from one or more national competent authorities (NCAs), managed sequentially.
  2. Centralised EU scientific advice through the EMA.

There are pros and cons for each route that companies have to consider in deciding which route to choose.

It was announced earlier this week that the EU Innovation Network has introduced a pilot programme to support obtaining national scientific advice from two NCAs simultaneously. This is with a view to:

  • shortening the timelines to obtain national advice from two NCAs
  • identifying divergent opinions and aiming for aligned NCA advice
  • optimising resources

It is indicated that there will be special guidance for SMEs, especially for requests for early advice.

Which NCAs are in?

Participating NCAs are Austria, Belgium, Czech Republic, Finland, Germany (BfArM and PEI), Hungary, Italy, Norway, Poland and Spain. More NCAs may join during the pilot.

And after the pilot?

The pilot is planned to run for about a year. Based on both industry and regulators feedback, and demand for SNSA, this procedure may continue alongside the current approaches for scientific advice and also be widened to include more than two NCAs in a single SNSA procedure.

How can S-cubed help you?

S-cubed is working with client companies to obtain scientific advice via both the centralised process through EMA, and also through one or more NCAs. This new simultaneous procedure presents an interesting new option for consideration.

Any Questions?

If you have any questions on this topic, please don’t hesitate to ask! You can contact us through our website (www.s-cubed-global.com), via email (info@s-cubed-global.com), and telephone (S-cubed Ltd: +44 1235 77 22 60).

References

https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants-pilot-simultaneous-national-scientific-advice-snsa_en.pdf

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