In anticipation of the new clinical trials regulation (Regulation No. 536/2014 dated April 16, 2014) that will repeal the current clinical trials directive (Directive 2001/20/EC), the French National Drug and Health Product Authority ("ANSM"), in conjunction with the 39 existing Ethics Committees ("EC"), is offering sponsors the opportunity to participate in a "pilot phase" in order to anticipate the next stages in the organization and coordinate assessments carried out by voluntary ECs and the ANSM, respectively. The purpose of the pilot phase is to ensure that France is ready when the European Regulation comes into force.
On August 11, 2016, ANSM published a "Practical Information Guide for Applicants" regarding clinical drug trials submitted within the pilot phase. According to the ANSM guide, a sponsor may either apply the regular current French procedure or choose to participate, on a voluntary basis, in the experimental Pilot Phase proposed by the ANSM, which is described in the Guide. Although the EU portal, which will be the single entry point for submitting clinical trials applications in the EU, is not effective yet, the ANSM attempts to simulate the new procedure by: (i) requiring a parallel, simultaneous submission of the application to the ANSM and the competent French EC; (ii) coordinating the assessment period and dialogue between the ANSM and the ECs, since the current procedure provides for separate applications to both bodies; and (iii) complying with the schedule and deadlines provided by the European Regulation.
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