SNSA pilot 2 starts

The simultaneous national scientific advice (SNSA) pilot programme of the EU Innovation Network, enabling concurrent participation of two or more national agencies, continues to the second phase.

In the future, the applicant can request simultaneous national scientific advice in several EU countries at the same time within the same advice process. This advice format is offered as a phase 2 pilot that will run for a two-year period until the end of 2024. The pilot is open to applicants from large to small and medium-sized pharmaceutical companies, academic research centres and hospitals.

The advice format intends to promote consistent quality, and it is especially aimed for applicants for scientific advice related to clinical trials within the European Union. The following opportunities to drug developers were identified during the planning of the format:

• More 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 procedure.
• The SNSA procedure would bring added value to academic researchers when applying for funding and grants to support non-commercial clinical trials.
• The process is also intended to support informing the early-stage development of innovative products in the centralised procedure, especially where there is limited existing regulatory guidance. 
• Advice may also be provided prior to clinical trials when a new innovative therapeutic indication is planned to be applied for an authorised medicinal product.

Guidance to applicants and the application form are published 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)

The SNSA process is coordinated by the German Medicines Agency (PEI), and applications for SNSA should be sent to: SNSA@pei.de.

You can find more information on SNSA on the Fimea website:

Fimea online news article 31 January 2020: The SNSA pilot starts

Advice and support for drug development

Supervision of clinical trials