French Regulator Wants More Trial Sponsors To Take Part In Pilot Of Future EU Procedures
A French pilot project testing out the future EU clinical trial authorization procedures has borne fruit after the first two years, but the regulator wants many more sponsors to use the pilot so that the country is ready for the new rules in 2019.
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Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.
Belgium is following the footsteps of Germany and France by launching a pilot to develop and test procedures for the coming EU Clinical Trial Regulation, which requires national competent authorities and ethics committees to evaluate trial dossiers in parallel and to issue a consolidated single decision within short timelines.
The French government has launched a pilot project1 intended to allow drug companies to familiarize themselves with the new procedures that will kick in when the provisions of the EU's Clinical Trials Regulation take effect in a couple of years' time.