EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot

The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot.

The EU IN started Phase 1 of the pilot for Simultaneous National Scientific Advice (SNSA) from the National Competent Authorities (NCAs) in February 2020. The pilot was extended to the end of 2021. You can read more about Phase 1 in a previous blog post here.

What is the intended use of SNSA?

SNSA is intended to be used in situations where an applicant wishes to obtain national scientific advice from more than one NCA at the same time. The format is intended to enhance the quality and consistency of such advice.

How is Phase 2 of the SNSA pilot different from Phase 1?

Phase 2 of the SNSA pilot builds on the success of the first phase of the pilot. It optimizes the procedure, while maintaining the key principles associated with SNSA.

The optimized pilot SNSA process will continue to complement and provide a bridge between purely national scientific advice and centralised European scientific advice procedures from EMA as well as supporting the aims of the ACT-EU initiative and the CTCG.

Is there a specific focus in Phase 2 of the SNSA pilot?

Yes there is.

In conjunction with the ACT-EU initiative, this phase of the SNSA pilot will have a specific focus on scientific advice to facilitate clinical trials (CT) within Europe. It will enable sponsors/ developers to obtain clinical trial-related national scientific advice from National Competent Authorities (NCA) in Member States (MS) where they intend to perform clinical trials. 

Who can use Phase 2 of SNSA pilot?

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.

How long will Phase 2 of SNSA pilot run for?

Following endorsement by the Heads of Medicine Agencies (HMA), phase 2 of the SNSA pilot will run for a two-year period until the end of 2024.

Are there any examples of scenarios in which developers might choose to seek simulatenous national scentific advice (SNSA)?

The following are examples of scenarios where developers may choose to seek SNSA:

  • In preparation for clinical trials (CT) applications to be performed in more than one MS. Where during the SNSA the involved NCAs agree that the questions raised would benefit from discussions at the Clinical Trial Coordination Group (CTCG) level, it is also possible to obtain CTCG-coordinated clinical trial expert feedback 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 centralized marketing authorisation application.
  • Prior to clinical trials intended to facilitate repurposing of authorised medicinal products e.g. to support new innovative therapeutic indications

Is there any more detail available on what might happen in each SNSA Procedure?

Yes there is .

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.

How will the experience gained from Phase 2 of the pilot be used?

The experience gained during the SNSA pilot will be used to further develop the process and the provision of clinical trial-related advice as part of ACT EU Priority Action 7 (ACT EU PA7)

Where can you obtain further information?

The document entitled Guidance for applicants on Simultaneous National Scientific Advice (SNSA) phase 2 pilot (from October 2022) – Optimized process is available here.

Guidance on SNSA briefing book format, list and contacts of participating NCAs, an application form as well as links to sources of additional information are available here.

Source: HMA website