France – Update of national early meetings guide for medicines evaluation

As part of its action plan for innovative medicines and its work programme presented at the beginning of 2020, the HAS has revised its guide to early meetings which aims to support businesses in the clinical development of new medicines. The guide was designed to improve the predictability and speed of the HAS response to those businesses.

This HAS mission, provided for in Article L161-37 of the French Social Security Code, consists of providing applicants with recommendations on the clinical development of health products and the type of data expected during their evaluation.

The update of this guide introduces several new features such as:

• An additional fast-track procedure that now makes it possible to obtain written replies from the HAS within 75 days.
• The integration of patient perspectives into the HAS positions.
• Improved predictability of the procedure, with a fixed timetable for the organisation of the procedure being posted online.
• A briefing document clarifying HAS expectations, particularly regarding real-life data and patient reported outcomes.

Finally, the guide explains that all documents will be exchanged electronically via the Sesame online platform.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2020 Issue (Thomson Reuters).