European Clinical Trials Regulation

The European Parliament voted on the text of the new Clinical Trials Regulation

Undertaking Follow Up

The Academy's 2011 report 'A new pathway for the regulation and governance of health research' highlighted the need for a full revision of the EU Clinical Trials Directive 2001/20/EC. The report emphasised the need to amend the Directive to ensure a more proportionate approach to the approval and monitoring of clinical trials of the safety or efficacy of medicines.

In July 2012 the European Commission published proposals for a new Regulation to replace the Clinical Trials Directive. The Academy has undertaken a number of activities to influence the development of the Regulation, including: convening stakeholder meetings; developing joint briefings and statements; and responding to consultations.

The European Parliament voted on the text of the new Clinical Trials Regulation April 2014. It is anticipated that the provisions of the new Regulation will become applicable in mid/end 2016. 

We will continue to liaise with our partners to monitor the implementation of the Regulation, especially on issues such as the development of the EU portal and database and to ensure that the Regulation's vision of greater risk proportionality is adopted by regulators across all processes from authorisation to monitoring of trials and GCP inspections.

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