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
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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