EMA delays enforcement of new Clinical Trial Regulation

EMA will not enforce the new Clinical Trial Regulation as planned in May 2016 – 2017 is more likely

The December meeting of the European Medicines Agency's management board offered tidings of less than total comfort and joy to the clinical trials community. The agency's holiday message was a disappointment to those hoping for rapid progress on bringing Europe's new clinical trials rules into effect. The legislation, finalized in May last year—that is, 2014—said the new regulation would not be in force before May next year—that is, 2016. But the EMA board, which had already admitted that 2017 was a more likely date, disrupted the festive season with the news that the horizon for the clinical trial rules had shifted still further away, and is now October 2018.

The announcement has provoked some sharp reactions among those battling with the incoherencies of the EU's current rules on clinical trials—which the new regulation was designed to remedy. The agency's protestations of the need for a meticulous approach have not assuaged the impatience of development staff still laboring through the complexities of the much-criticized 2001 directive.

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