Guidance for Applicants on Simultaneous National Scientific Advice (SNSA) Phase 2 Pilot (from October 2022) – Optimized Process

21 November 2022 – EMA updated the guidance for SNSA phase 2 pilot.

The objective of the concept is to establish a more efficient procedure for applicants who wish to seek advice on the same set of questions and data package from different NCAs. The aim of an SNSA request is to advise the Applicant in a targeted way on the specific questions that are being raised and not to perform a pre-assessment of the complete formal application(s) to which the SNSA request. 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 authorization application.

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