The EU Clinical Trials Regulation
Produced in partnership with Eveline Van Keymeulen of Allen & Overy and Marco de Morpurgo
The EU Clinical Trials Regulation

The following Life Sciences practice note Produced in partnership with Eveline Van Keymeulen of Allen & Overy and Marco de Morpurgo provides comprehensive and up to date legal information covering:

  • The EU Clinical Trials Regulation
  • New EU regulation on clinical trials
  • Purpose of the CTR
  • Key changes
  • Nature of the CTR
  • Scope of the CTR
  • Low-intervention clinical trials
  • EU portal and database
  • EU portal
  • EU database
  • More...

New EU regulation on clinical trials

This Practice Note covers the new Regulation (EU) 536/2014 on clinical trials, the Clinical Trials Regulation (CTR). It reviews the main changes introduced by the CTR to the EU regulatory framework applicable to clinical trials, and discusses the key aspects that clinical trial sponsors and pharmaceutical companies must be aware of as the CTR application date approaches.

On 16 April 2014, the European Parliament and the Council of the EU adopted Regulation (EU) 536/2014 on clinical trials on medicinal products for human use, the CTR.

From its date of application (which is expected to be during 2021, see: Application date), the CTR will repeal and replace the current regulatory regime for clinical trials laid down by Directive 2001/20/EC (consolidated version) on clinical trials on medicinal products for human use, the Clinical Trials Directive (CTD), as amended, and implementing legislation of the EU Member States.

Purpose of the CTR

The regulatory framework on clinical trials established by the CTD was widely criticised by stakeholders for being too fragmented and 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 conducted in the EU since the adoption of the CTD (there had been a reduction of about 25% at the time of adoption of the CTR).

With the objective of re-establishing

Popular documents