SNSA advice

The EU Innovation Network has launched the SNSA (Simultaneous National Scientific Advice) pilot project in which national scientific advice will be made available to an applicant who wishes to get it simultaneously from two or more EU member states under the same scientific advice process. The advice format, which has been approved by the Heads of Medicines Agencies (HMA) is being offered as Phase 2 of the SNSA pilot project running until the end of 2024.

The advice format is designed to enhance quality and consistency of the advice provided by the national agencies, offering the possibility to handle differences in the views taken by the national competent authorities. In conjunction with the Accelerating Clinical Trials in the EU (ACT EU) initiative, this phase of the SNSA pilot project has a special focus on facilitating the launch of clinical trials (CT) within the EU area. Another purpose is to facilitate sponsors/medicine developers to obtain clinical trial-related scientific advice from the national competent authorities of those member states in which the clinical trials are intended to be performed. Experience from the SNSA pilot will be used for the further development of the advice process and advice on clinical trials in accordance with the ACT EU Priority Action 7 (ACT EU PA7).

The following scenarios for drug developers were identified during the planning of the format:

Preparing applications for the clinical trials planned to be submitted to more than one member state. Parties preparing clinical trials (CT) to be performed in more than one EU Member State would be able to receive expert feedback coordinated by the Clinical Trial Coordination Group (CTCG) as part of the SNSA advisory process. This requires approval from the national authorities involved in the given scientific advice on the benefits of the discussion at the Clinical Trial Coordination Group (CTCG) level concerning the questions that have been raised.
The academic researchers would gain added value from the SNSA process when applying for funding and grants to support the implementation of non-commercial clinical trials.
The process is also meant for the early-stage innovative developments especially in situations in which available regulatory guidance is scarce or limited. Centralised advice should still be sought from the European Medicines Agency in cases concerning the suitability of the clinical programme to support a centralised marketing authorisation application.
Advice may also be provided before the clinical trials are launched, e.g. when a new innovative therapeutic indication is planned for a medicinal product already on market.

The pilot is open to all applicants, including large pharmaceutical companies, and its purpose is to encourage pharmaceutical SMEs to seek scientific advice and to give encouragement especially to academic research centres and hospitals to get advice for their own development programmes.

Guidance for applicants and the application form are available on the websites of the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA).

Heads of Medicines Agencies: EU-Innovation Network (EU-IN) (hma.eu)

European Medicines Agency (EMA): Accelerating Clinical Trials in the EU (ACT EU)