Joint Research Office


EC to simplify clinical trials regulation

23 July 2012

The European Commission is planning to scrap the current Clinical Trials Directive of 2001 and simplify the rules for conducting clinical trials in a bid to boost clinical research in Europe.

The proposed legislation, which takes the form of a Regulation and is expected to come into effect in 2016, will make the rules for conducting trials identical throughout the EU and so should make it easier to conduct multinational trials.

Proposals include:

  • authorisation procedure allowing for fast assessment of an application by all states concerned and with one assessment outcome
  • simplified reporting procedures, sparing researchers from submitting identical information to different bodies
  • more transparency on whether recruitment to a trial is still ongoing and on the results of a clinical trial.

The proposals will also better differentiate the obligations according to the risk-profile of the trial.

The Commission points to the 'unfavourable regulatory framework for clinical research' which contributed to a 'decrease of 25% of clinical trials conducted in the period between 2007 and 2011'.

The proposal will now go through the EU decision-making process.

For more information go to the EC press release.