The European Innovation Network (EU IN) has launched phase 2 of the simultaneous national scientific advice (SNSA) pilot project. SNSA can be used when an applicant wants to obtain national scientific advice from more than one national competent authority (NCA) at the same time. The format is designed to enhance the quality and consistency of such advice. Following endorsement by the Heads of Medicines Agencies (HMA), phase 2 of the SNSA pilot project will run for a two-year period until the end of 2024. Phase 2 incorporates an optimised procedure to maximise the benefits for both applicants and competent authorities.
In conjunction with the Accelerating Clinical Trials in the EU initiative (ACT EU), this phase of the SNSA pilot project will have 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 NCAs in member states (MS) where they intend to perform clinical trials. The experience gained during the SNSA pilot project will be used to further develop the process and advice on clinical trials under the ACT EU Priority Action 7 (ACT EU PA7).
The following are examples of scenarios for which developers can apply for SNSA.
- To prepare for clinical trial (CT) applications to be performed in more than one MS. If the involved NCAs agree during the SNSA that the questions raised would benefit from discussions at the Clinical Trial Coordination Group (CTCG) level, it is also possible to obtain feedback from CTCG-coordinated clinical trial experts as part of the SNSA procedure.
- Prior to applying for funding grants to support non-commercial clinical trials (academic researchers).
- To inform the early-stage development of innovative products for which clinical trials are planned (e.g. phase I/II clinical trials) especially where there is limited existing regulatory guidance. EMA scientific advice should continue to be used for scientific advice related to the suitability of the proposed clinical development to support a centralised marketing authorisation application.
- Prior to clinical trials intended to facilitate repurposing of authorised medicinal products, e.g. to support new innovative therapeutic indications.
The pilot project is open to applicants from different backgrounds including large pharmaceutical companies, while strongly encouraging small and medium enterprises (SMEs) and particularly inviting academic research centres and hospitals to join.
How to apply for SNSA?
Guidance on how to prepare and submit a formal SNSA application and relevant templates are listed below:
- Guidance for applicants
- Guidance on SNSA briefing book format and content
- List of participating NCAs and contact information
- Application form