Europe – Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA)

Developers of medicinal products or medical devices and other technologies seek national scientific advice to optimize prospectively their development programme. Scientific advice can be received nationally from national competent authorities (NCAs), or centrally coordinated by EMA. Experience has shown that national advice is often requested from more than one NCA. In order to optimize resources on both sides and improve the regulatory support, a new approach has been developed: in one single step national scientific and/or regulatory advice can be requested with two NCAs simultaneously. The objective of the concept is to establish a more efficient procedure for applicants seeking advice for the same set of questions and data package from different NCAs based on the
existing principles and structures. Thus, the new approach is envisaged to be a complementary tool to the established regulatory/scientific advice procedures at national or European level without duplicating existing advice procedures.

The focus of the SNSA is on innovative developments to identify the needs of the applicants to enhance innovation and avoid gaps in early regulatory support. The pilot aims at exploring the opportunities and interest in providing such coordinated national scientific advice particularly to developers of new medicines and therapies…