What is it called?

Regulation (EU) 536/2014 on clinical trials on medicinal products for human use (the “Clinical Trials Regulation”) will replace the Clinical Trials Directive (Directive 2001/20/EC).

The application of the Clinical Trials Regulation has been delayed several times, as a fully functional EU clinical trials portal and database is a pre-requisite to its application. However, the European Commission published a notice on 31 July 2021, to confirm that the application date would go ahead on 31 January 2022.

What is it about?

The Clinical Trials Regulation seeks to ensure a greater level of harmonisation between the individual EU Member States of the rules for conducting clinical trials in the EU by:

  • Although it will not create a single authorisation the Regulation will introduce a single submission and review process via an EU portal known as the “Clinical Trials Information System” (CTIS), maintained by the European Medicines Agency (EMA);
  • Providing for a centralised assessment procedure;
  • Harmonising rules on the protection of participants in clinical trials and patient informed consent including the possibility of patient consent for present and future use of data and samples.;
  • Setting out minimum transparency requirements for the conduct of clinical trials and reporting of results.

Note that the authorisation and oversight of individual clinical trials will remain the responsibility of individual Member States, with the EMA simply managing the CTIS system.

To whom and what does it apply?

The Clinical Trials Regulation will apply to all new clinical trials conducted in the EU, as well as trials that were authorised under the Clinical Trials Directive and are still ongoing three years after the Regulation begins to apply (so those ongoing on 31 January 2025).

Why does it matter?

The Clinical Trials Regulation represents a major shift in the way clinical trials are approved and supervised  in the EU.

To date, under the Clinical Trials Directive, national rules around the conduct and assessment of clinical trials have varied by Member State. This has led to significant burdens for companies wishing to conduct multi-jurisdictional clinical trials., The EMA has stated that the new Clinical Trials Regulation will make it easier for companies to organise this type of trial, encouraging more clinical trials to be conducted within the EU whilst also ensuring a high standard of safety for participants.

Where can I find it?

The Clinical Trials Regulation can be found here.

Training on the operation of the CTIS is available via the EMA here.

Posted by Julia Maskell