Regulatory Focus™ > News Articles > Breaking: European Commission Adopts Proposal for a 'Clinical Trials Regulation'

Breaking: European Commission Adopts Proposal for a 'Clinical Trials Regulation'

Posted 17 July 2012 | By Louise Zornoza 

The European Commission has issued a proposal to revamp the rules governing clinical trials.   The proposed legislation will replace the "Clinical Trials Directive" of 2001, and will take the form of a regulation, ensuring that the rules for conducting clinical trials are identical throughout the EU. 

In particular, it will make it easier to conduct multinational clinical trials in Europe. Some concrete proposals are:

  • An authorization procedure for clinical trials, which will allow for a fast and thorough assessment of the application by all Member States concerned, and which will ensure one single assessment outcome.
  • Simplified reporting procedures, which will spare researchers from submitting largely identical information on the clinical trial separately to various bodies and Member States.
  • More transparency on whether recruitment for participating in a clinical trial is still ongoing, and on the results of the clinical trial.
  • The possibility for the Commission to conduct controls in Member States and other countries to make sure the rules are being properly supervised and enforced.

The legislative proposal will now be discussed in the European Parliament and in the Council. It is expected to come into effect in 2016.

Read more:

Revision of the Clinical trials Directive

Read more Breaking News from RegLink


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