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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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.
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.
The European Medicines Agency will hold a webinar to explain and demonstrate specific functionalities of the new clinical trials system relevant to clinical trial sponsors.