French To Test Future EU Clinical Trial Procedures For Drugs
This article was originally published in SRA
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.
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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.
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.
From next year, more agencies will be involved in the UK’s regulatory reliance procedure for new drug approvals, which was first introduced in 2021 to allay fears of post-Brexit delays to UK applications. The pharmaceutical industry said it looked forward to working with the regulator on the new framework.