New clinical trial rules in the EU: a first overview

Regulation (EU) No 536/2014 (‘the Regulation’) on clinical trials on medicinal products for human use has been 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.

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use will repeal the current regulatory regime for clinical trials laid down by Directive 2001/20/EC (‘the current regime’). The current regime has been widely criticised by all stakeholders for having increased the regulatory burden and costs of conducting clinical trials in the EU, resulting in a significant decline in the number of trials since the adoption of the Directive.

With the objective of re-establishing the EU’s competitiveness in the field of clinical research, the Regulation introduces a single, harmonised regulatory regime that applies to all clinical trials conducted in the EU. The new system will operate through a single EU portal through which applications for clinical trials will be processed and through which the relevant information will be stored in a single EU database. The information in the database will be publicly accessible…

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