On 25 January 2017, the French National Agency for Medicines and Health Products Safety (ANSM) published the first year 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 apply once the EU Clinical Trials Regulation (CTR) (536/2014/EU) becomes applicable (expected no earlier than 2018).
France was the first country to test the new procedures through this voluntary pilot phase. 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 ethics committee (CPP) within 60 days, thus reflecting the CTR’s requirements.
The results indicate that the pilot phase was successful in different respects, in particular:
- Both sponsors and all CPPs have shown keen interest and collaborated with the ANSM on this experimental project. In the second six-month period of the project, all CPPs participated, in contrast with the first six-month period where only 21 out of 39 CPP participated.
- Between 28 September 2015 and 30 September 2016, 112 trial applications out of 897 (12.5%) were filed under the pilot (62 by industry and 50 by academia). The applications covered all trial phases (I, II, III or IV) and a variety of therapeutic areas. Almost 80% of those trial applications (89) were completed by 30 September 2016. Of those completed applications, 82% (73) were authorised by the ANSM and received a positive opinion from the relevant CPP.
- The time frames for administrating applications were met at each stage of the process for all applications, with an average notification time of 64.3 days.
In the light of this positive assessment and the new legislative and regulatory provisions, the ANSM has issued an updated version of the accompanying guide for applicants entitled “Practical information guide for applicants in the pilot phase“.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2017 Issue (Thomson Reuters).