In February 2020, the EU Innovation Network started a pilot for Simultaneous National Scientific Advice (SNSA) from the National Competent Authorities (NCAs), which was extended until early 2022 due to the COVID-19 pandemic. This initial pilot allowed innovators to access scientific advice simultaneously in different EU member states, establishing a more efficient procedure for applicants wishing to seek advice on the same set of questions and data packages.

Phase 1 of the pilot proved to be successful, with more than 33 pilot requests being received across multiple therapeutic areas and therefore HMA endorsed a second pilot phase to run for a two-year period, until the end of 2024.

Phase 2 of the pilot will focus on delivering an optimised process, increasing efficiency and transparency and will include the following:

• Commonly agreed predictive timelines
• Common application form
• Additional NCAs included the pilot
• Option for a third NCA to participate as an observer in the SNSA process
• Ability for clinical trial related scientific advice to be obtained from NCAs in Member States where they intend to perform clinical trials

The scope of Phase 2 SNSA will remain generally the same, limited to medicinal products for human and veterinary use as well as drug-device combination products, where these already fall within the remit of the regulatory scientific advice services provided by the participating NCAs. Any applicant can apply for the SNSA pilot, with special support provided to academia and SMEs in preparing for the SNSA, especially those with innovative or complex development programmes.

DLRC have extensive experience supporting clients as they apply for National Scientific Advice, for more information contact us at enquiries@dlrc.co.uk or use the form below.

Full Guidance for Applicants on SNSA Phase 2 Pilot can be found here.