SNSA is intended for situations where an applicant wishes to obtain scientific advice from two national competent authorities (NCA) at the same time (with the option for a third NCA to participate as observer in the SNSA procedure). The objective of this initiative is to enhance the quality and consistency of scientific advice received by the applicant.
Phase 2 of the SNSA pilot builds on the success of the first phase of the pilot, which took place in 2020. It optimizes the procedure, while maintaining the key principles associated with SNSA, in order to maximise the benefits for both applicants and competent authorities. The pilot is open to applicants from different backgrounds including large pharmaceutical companies, while strongly encouraging SMEs and especially inviting academic research centres and hospitals to join. This phase of the SNSA pilot has a specific focus on scientific advice to facilitate clinical trials (CT) within Europe. It will facilitate sponsors / developers to obtain clinical trial-related national scientific advice from NCA in Member States (MS) where they intend to perform clinical trials.
Within each SNSA procedure, each participating NCA will prepare and discuss their positions on the questions raised by the applicant with a view to maximising alignment prior to a joint advice meeting with the applicant. Where divergent positions remain, these will be explained to the applicant in the joint advice meeting and subsequently be summarised in consolidated meeting minutes with a view to facilitating further consideration and appropriate follow-up upon agreement of the applicant.
Which NCAs are in?
Participating NCAs are Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany (PEI), Hungary, Ireland, Italy (as observer), Netherlands (MEB, CCMO as observer), Norway, Poland, Portugal, Sweden and Spain. This list is subject to change and will be regularly updated as additional NCA’s may consider participating in the course of the pilot (List of NCA’s participating in the Simultaneous National Scientific Advice (SNSA) pilot phase 2 (europa.eu)).
What’s the process?
- The applicant selects two NCAs from the list of participating NCAs and sends a request to the central contact point including the common SNSA application form, a draft list of questions and a brief outline of the scope of the SNSA request.
- By mutual agreement, one NCA is designated as the coordinating NCA and takes responsibility as the lead for the procedure and the timeline of the SNSA is determined.
- The applicant sends a complete briefing package to be validated by the coordinating NCA, and the SNSA meeting is scheduled at the latest 60 days after the formal start of the procedure.
- The consolidated final advice incorporating the positions of each of the participating NCAs is finalised and disseminated by Day 90 at the latest.
And after the pilot?
This second pilot phase will run for a two-year period. At the end of this period, a further evaluation will be performed to analyse the experiences of the optimised SNSA procedure both from NCA’s and applicant’s perspective. The outcome of that evaluation will inform the next steps in relation to the SNSA concept to be agreed with HMA. In the event that the pilot is successful, options could include further optimisation of the SNSA procedure including the participation of additional NCAs in each 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 phase 2 pilot of the simultaneous advice procedure presents a worthy option for consideration.
Innovation in medicines | European Medicines Agency (europa.eu)
Guidance for applicants on Simultaneous National Scientific Advice (SNSA) phase 2 pilot (from October 2022) – Optimized process (hma.eu)