EU-Innovation Network (EU-IN)

STARS was an EU-funded project that run between 2019 to 2022. It assessed the level of knowledge of academic drug researchers on regulatory sciences and the training offered in this area. The STARS Common Strategy summarises the achievements of the project and opportunities to strengthen regulatory science and knowledge.

For more information:
 

• STARS
• STARS overview - leaflet

As part of its mandate, the EU-IN promotes the involvement and collaboration of competent authorities in relevant externally-funded projects. To facilitate this, the EU-IN has developed guidance for researchers and project teams outlining the circumstances under which competent authorities may engage in such projects related to medicinal products. This guidance also specifies the information that should be submitted when seeking a competent authority’s involvement. Any existing position / guidance established by individual competent authorities on this matter should be considered.
 

• Involvement of competent authorities in externally funded projects

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 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 (MS).
• Planned marketing authorisation 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 snsanoSpam@noSpamfagg-afmpsnoSpam.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 on how to prepare and submit a formal SNSA request and relevant templates are listed below:
 

• Guidance to applicants
• Guidance on SNSA briefing book format and content
• List of participating NCAs and contact information (updated April 2025)
• Procedural Flow chart
• Application form
• Feedback Questionnaire
• Meeting Minutes Template
• Advice Report Template

For any further information, please contact snsa@fagg-afmps.be.


Additional documents
 

• Simultaneous National Scientific Advice (SNSA) - Continuation and further development during 2025
• National Scientific Advice Contacts
• National Innovation Offices Contacts

Additional information

Key features of the current 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

Practical information on how to submit an SNSA request is also available on the websites of the NCAs participating in the SNSA pilots (cfr. List of participating NCA’s and contact information) and on the  EMA website.