On 22 June 2017, the French National Agency for Medicines and Health Products Safety (ANSM) published the 18-month results of its clinical trials pilot project which was launched in September 2015. The project was established to test the new EU clinical trial procedures that will enter into place once the EU Clinical Trial Regulation (Regulation (EU) No 536/2014/EU) becomes applicable (postponed to 2019).
The 18-month results take into account the regulatory changes relating to research on humans and the integration of the 39 French ethics committees (ECs) that recently entered into force (see our previous post here). The results confirm previous findings of the pilot phase, in particular:
- Sponsors and all ECs have shown keen interest and collaborated with the ANSM on this experimental project. In contrast with the first six-month period where only 21 out of 39 ECs participated in the project, all ECs participated in both the second and third period of the project.
- Between 28 September 2015 and 31 March 2017, 152 trial applications out of 1292 (13.3%) were filed under the pilot. The applications covered all trial phases and a variety of therapeutic areas. 128 of those trial applications (84.2%) were completed by 31 March 2017. Of those completed applications, 98 (76.6%) were authorised by the ANSM and received a positive opinion from the relevant ECs.
- The average time frame for administrating applications was 65.5 days.
Through this voluntary pilot phase, France was the first country to test the new EU clinical trial procedures, and it did so to reinforce its position as an attractive clinical trial hub in Europe. The project uses a single submission point for trial applications and commits to issuing a single notification to sponsors, including both the ANSM decision and the opinion of the relevant EC, within 60 days, in accordance with the CTR’s requirements.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2017 Issue (Thomson Reuters).