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EMA Has Work Cut Out Before New Clinical Trial Portal Goes Live

Executive Summary

Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.

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EMA Explains Dos And Don’ts Of New Clinical Trials Portal

Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.

EU Clinical Trials Regulation To Apply From December 2021

Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi. 

Yet More Delay For EU Clinical Trial Regulation

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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