Extension of the EU pilot project on simultaneous national scientific advice

April 14, 2022

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.

Source: FAMHP

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.

Read more.