Yet More Delay For EU Clinical Trial Regulation
Original Deadline Of October 2018 Has Slipped To Early 2022
Revisions and restructuring of the contract with the developers mean that Europe’s new clinical trials system will not go live next year as planned, although the European Medicines Agency says progress has been made with development of the system.
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A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
The European Medicines Agency’s management board has agreed a revised go-live date for the new clinical trial information system. The new date is 'aspirational' and might change again depending on how the system fares in an ongoing independent audit to ascertain its full functionality.
An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.