Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year.

It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify and harmonize the administrative provisions for clinical trials of investigational medicinal products across the EU but did not achieve this, because, as it has been implemented differently across member states. It is also blamed for increasing the administrative and regulatory burden in the EU, making it a less attractive location for running clinical trials. However, it cannot be solely attributed to the Clinical Trials Directive that the number of clinical trials in Europe has declined, and the costs of trials have increased since it was implemented but it does appear to have contributed significantly to this.

The new Clinical Trials Regulation introduces an overhaul of the existing regulation of clinical trials for medicinal products in the EU. As a regulation, it will be directly binding in all EU member states without the need for any national implementing legislation. The aim is to streamline the clinical trial authorization and harmonize requirements for clinical trials in Europe.

The Clinical Trials Regulation is expected to come into force in May 2016 following the full functionality being in place of a new EU Database infrastructure and single online EU Portal created under the new Regulation.