FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
Trials Information System (CTIS), a centralised EU- wide electronic platform introduced by the CTR, and must include all information listed in EU law. CTIS has improved the performance of multinational trials by enabling sponsors to submit one online application for approval to run a clinical trial in several EU countries. Upon submission to the ANSM, the application under- goes a validation review completed within ten days from the date of receipt. If the application is incom- plete, the sponsor is granted ten additional days to provide the missing information. Upon receiving addi- tional documents, the ANSM has five days to review updates and notify the sponsor of validation or rejec- tion. Once validated, the application undergoes a scien- tific assessment by the ANSM and ethical assessment by the competent ethics committee (CPP) in France, within 45 days. In the event of requests for additional information, the evaluation period is extended by a maximum of 31 days. A new “fast-track” national procedure provides for an accelerated pathway for certain categories of single-national clinical trials. The fast-track authorisation period can be 14 days if the promoter’s application does not raise any questions following the evaluation by the ANSM and the CPP. For multinational trials, the scientific assessment is a joint decision among the health authorities of the involved EU member states. The final decision is notified to the sponsor via CTIS within a maximum of five days following the later date between the scientific assessment report and the ethi- cal assessment report. Medical Devices For medical devices, clinical trials are not systemati- cally required. They are mandatory for Class III and implantable devices (unless exempt). Applications must be submitted electronically to the ANSM, together with the documents referred to in EU law. The new application procedure under the MDR, which mandates submission via the European Data- base on Medical Devices (EUDAMED) using the Clini- cal Investigations and Performance Studies Module,
is not yet fully applicable. Until its full implementa- tion, national procedures remain in effect. The first four EUDAMED modules are now operational, and their use will be mandatory as of May 2026. From this date onwards, new medical devices will have to be registered in EUDAMED before being placed on the market. Medical devices already commercialised before this date benefit from an extra delay to be reg- istered in EUDAMED. Upon submission, the application undergoes a vali- dation review co-ordinated by the ANSM, completed within ten days from the date of receipt. If the appli- cation is incomplete, the sponsor is granted ten addi- tional days to provide the missing information. Upon receiving additional documents, the ANSM and the ethics committee have five days to review updates and notify the sponsor of validation or rejection. Once validated, the application undergoes a scientific assessment by the ANSM and ethical assessment by the ethics committee, within 30 to 65 days, depend- ing on the category of clinical trial (which is deter- mined primarily based on the purpose and status of the medical device). The final decision is notified to the sponsor. 2.3 Public Availability of the Conduct of a Clinical Trial Pharmaceuticals Since January 2025, all clinical trials on pharmaceu- ticals must be registered in the CTIS. Sponsors are required to submit trial results within one year of com- pletion, after which the data is published on CTIS. Clinical trial information was previously available in the EU Clinical Trials Register. Medical Devices There is currently no publicly accessible database for clinical trials on medical devices. However, the first four modules of EUDAMED have become operational and a transition period is currently underway until May 2026, prior to the mandatory registration of new medical devices. An extra delay for the mandatory registration in EUDAMED has been granted to medi- cal devices which have already been commercialised.
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