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. 

Clinical trial
The EU's new clinical trial regulation has hit another delay • Source: Shutterstock

The implementation of the EU Clinical Trial Regulation (CTR) will be delayed again after it was announced that the audit of the planned Clinical Trials Information System will not now begin until the end of 2020. This suggests that the system will not be in use until more than three years after the original deadline.

If the original delivery timescales for the various stages of the audit and application process are adhered to, the delay...

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