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New Clinical Trial Rules in the EU: A First Overview


03 June 2014

Last week, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was published in the Official Journal of the European Union. 

The Regulation establishes a single, EU-wide harmonised set of rules that will apply to all clinical trials conducted in the EU.  Most notably, the Regulation streamlines the authorisation procedures, simplifies specific sponsor obligations, and ensures public access to clinical trial information.  The Regulation will enter into force on 16 June 2014, but will not apply before six months have passed from the point at which the EU portal and database become fully operational, and in any event no earlier than 28 May 2016.


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