Continuation of Simultaneous National Scientific Advice (SNSA)

The Heads of Medicines Agency (HMA) has agreed to continue supporting Simultaneous National Scientific Advice (SNSA). This follows the positive evaluation of the results from the pilot project at a recent HMA meeting in January 2025.

The EU Innovation Network (EU-IN) has been running SNSA since February 2020. SNSA specifically targets scenarios where applicants may wish to seek national scientific advice relating to medicinal products from more than one national competent authority at the same time.

Examples of scenarios where SNSA could be used include:

• Preparation for planned clinical trials to be performed in more than one member state.
• Planned marketing authorisation applications using the decentralised or mutual recognition procedures.

We will continue to participate in SNSA and consider requests to join SNSA procedures.

Further developments in 2025

Over the coming months, the SNSA Working Group of the EU-IN will work on an optimised SNSA procedure taking into account the learnings from the pilot.

In the meantime, applicants can continue to submit new SNSA requests via email to snsa@fagg-afmps.be according to the currently available SNSA scope, procedure and timelines. Further details on the optimised SNSA procedure including associated guidance will be published later in 2025.

More information

Applicants can find more information on how to submit an SNSA request, including procedural guidance and application forms, on the HMA and EMA websites.