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Revising the EU Clinical Trials Directive

Last reviewed 
31 July 2013

The European Clinical Trials Directive 2001/20/EC is applied in UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004.  It regulates how clinical trials of a medicinal product in humans must be conducted, but has been implemented in different ways across the EU and has caused increased bureaucracy.

The European Commission has consulted on a proposal to revise the directive. The new legislation will be a regulation (to be consistent across the European states) and includes proposals to create a public EU-wide database for all clinical trials of new medicines, with a single portal for clinical trial applications and a streamlined system of review and authorisation. The regulation also requires the outcome of studies to be published in the database within a year of their completion, with fines imposed if sponsors do not comply.

What next?

The proposals are going through the approval procedures for the European Council and European Parliament; it is anticipated this will happen some time in 2014.