The Head of Medicines Agencies has approved the extension of the European pilot project for simultaneous national scientific advice at its 107th meeting in February 2022. The approval followed a positive evaluation of the first results of the project since its launch in February 2020.
Since February 2020, the EU Innovation Network has been running a pilot project for simultaneous national scientific advice (SNSA) from national competent authorities (NCAs) to further strengthen early regulatory support for innovation. The concept of SNSA is to offer national scientific advice from different NCAs at an early stage of development at the same time, optimising the quality and consistency of such advice while saving time and resources for the applicant. The NCAs will initially independently review the questions raised and then interact to ensure the maximum possible alignment of their positions prior to a joint advice meeting with the applicant.
Following a positive evaluation of the outcomes of pilot project phase 1 by the HMA in February 2022, the SNSA pilot project has been formally extended for two and a halve years. The HMA also approved the SNSA working group’s proposal to proceed to project phase 2 consisting of the following phases.
- Phase 2a (six months, from February till end of July 2022) will focus on the development of an optimised, common SNSA procedure between the participating NCAs as a best-practices model that could serve the future needs of different European initiatives and regulatory platforms.
- Phase 2b (two years running from August 2022 until August 2024) is intended to implement and pilot the optimised, common SNSA pilot process developed in Pilot project phase 2a and which will be subject to reporting back and evaluation at HMA level.
Further information will be disseminated to all relevant FAMHP stakeholders in due time when entering this second part of pilot phase 2.