Clinical Trials

Clinical Trials

The new EU Clinical Trials Regulation (Regulation No. 536/2014) will come into force in 2019.  The regulation aims at streamlining and simplifying rules in order to revive research activity in Europe, for example by introducing a unified application process through a single EU portal for cross-border trials.

Simplification of rules include:

• Streamlined application procedure via a single entry point – an EU portal and database, for all clinical trials conducted in Europe;
• Single authorisation procedure for all clinical trials, with assessment of application by all Member States concerned, with one single assessment outcome and authorisation per Member State;
• Extension of the tacit agreement principle to the whole authorisation process for more legal certainty for sponsors, researchers, SMEs and academics;
• Strengthened transparency for clinical trials data and new rules for informed consent for use of subjects’ data

For more information and for accessing documents in your language:

• European Commission: Clinical Trials – General Information
• Clinical Trials Regulation
• Clinical Trials guidelines
  • EMA Scientific guidelines
• EU Clinical Trials Register

Clinical Trial Facilitation Group (CTFG)