Since February 2020, the EU Innovation Network (EU-IN) has been running a pilot project for simultaneous national scientific advice (SNSA) from national competent authorities (NCAs). SNSA specifically targets scenarios where applicants may wish to seek national scientific advice 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 (MS) or planned marketing authorization applications using the decentralised or mutual recognition procedures.
Following a positive evaluation of the results of the SNSA pilot project at the 119th HMA meeting in January 2025, the HMA has supported the continuation of the SNSA concept.
Over the coming months, the SNSA Working Group of the EU-IN will continue to work on an optimised SNSA procedure taking into account the learnings 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.
How to apply for SNSA
- Guidance for applicants
- SNSA procedural flowchart
- List of participating NCA’s and contact info
- Application form
- Guidance on SNSA briefing book format and content
- SNSA meeting minutes template for applicants
- SNSA final advice report template
- Questionnaire for applicants on the Simulteneous National Scientific Advice (SNSA) pilot procedure
For any further information, please contact snsa@fagg-afmps.be
Additional Information
Key features of the optimized SNSA procedure include:
- An increased number of NCAs willing to participate in SNSA procedures.
- A common application form, briefing book template and a single-entry point (email to snsa@fagg-afmps.be) to reduce the administrative burden for applicants.
- The coordination group (PEI, FAMHP or AEMPS) will liaise with the leading MS who will act as the main contact point for the applicant during the procedure.
- A predictable timetable to be agreed prior to the start of each procedure.
- Each SNSA will involve two participating NCAs with the possibility of a third NCA joining as an observer. In special cases, when sufficiently justified by the Applicant, participation of a CTCG representative and/or an Ethic Committee representative in an SNSA request can be considered.
- In justified cases, e.g. where the request relates to a clinical trial to be performed in more than 2 MSs, the involvement of additional MSs in a single SNSA procedure will be considered subject to the agreement of the NCAs.
The following principles continue to apply:
- All types of applicants can apply for an SNSA pilot. Pre-submission guidance can be requested via the single-entry point for academia and SMEs to assist them in preparing their scientific advice request.
- Participation of an NCA in any individual SNSA procedure is on a voluntary opt-in basis.
- The scope of SNSA includes regulatory or scientific questions related to quality, safety and efficacy of medicinal products. Questions can relate to products under development as well as authorised products.
- The advice given will be limited to the scope of the questions raised by the applicant in the briefing document.
- SNSA is an opportunity for the applicants to discuss their queries with each of the NCAs involved in the procedure in a joint meeting with the possibility for the NCAs to raise questions related to clinical trials with the CTCG if considered appropriate.
- The outcome of each SNSA procedure is clearly documented and reflects the position of each of the involved NCAs.
- The fees for SNSA are based on the national scientific advice fees in each of the participating NCAs and should be paid directly to each participating NCA in the normal manner. There is no fee relating to the involvement of an NCA as an observer.
- Queries related to HTA and reimbursement are currently excluded.
