Since February 2020, the European Union Innovation Network has been running a pilot project for simultaneous national scientific advice provided by multiple national competent authorities at the same time. Following a positive evaluation of the results of the simultaneous national scientific advice pilot project at the Heads of Medicines Agencies meeting in January 2025, the continuation of the concept was supported.
In February 2020, the European Innovation Network (EU IN) launched the simultaneous national scientific advice (SNSA) pilot project. SNSA can be used when an applicant wants to simultaneously obtain national scientific advice from more than one national competent authority (NCA). For example: in preparation of planned clinical trials to be performed in more than one member state or planned marketing authorisation applications using the decentralised or mutual recognition procedures.
The FAMHP, which has actively been involved as co-chair of this European pilot project, wants to inform all stakeholders that the Heads of Medicines Agencies (HMA) has formally approved the continuation of the SNSA concept as a standardised, multi-national (consolidated) scientific-regulatory advice format from 2025 onwards.
In the coming months, the SNSA Working Group of the EU-IN will continue to work on an optimised SNSA procedure taking into account the lessons learned from the pilot. In the meantime, applicants can continue submitting new SNSA requests via snsa@fagg-afmps.be according to the currently available SNSA scope, procedure and timelines until further notice. Further details on the optimised SNSA procedure including associated guidance will be published later in 2025.
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