Q&A: New rules for clinical trials conducted in the EU – 2 April 2014

Posted on April 7, 2014. Filed under: Research | Tags: , |

Q&A: New rules for clinical trials conducted in the EU – 2 April 2014


“Why is the current legislation being replaced?

The 2001 Clinical Trials Directive has been criticised by patients, researchers and industry alike for its disproportionate regulatory requirements. High costs and a lack of harmonisation of the applicable rules necessary for multinational clinical trials are a few examples.

Taken together, these restrictions have contributed to a significant decline in the number of clinical trials in the EU – a reduction of about 25 % in the last few years.

The new Regulation aims at restoring the EU’s competitiveness in clinical research and the development of new and innovative treatments and medicines by cutting red-tape and bringing patient-oriented research back to Europe.

What are the main changes introduced by the Regulation?

The new Regulation will make it easier to conduct multinational clinical trials, i.e. conducted in more than one Member State, in the EU. Measures that cut red tape and simplify the current rules are:

– A straightforward authorisation procedure allowing for a fast and thorough assessment of the application by all Member States concerned and resulting in one single assessment outcome. The authorisation procedure allows the individual EU countries to determine the roles of the bodies in charge of the assessment, on the condition that the assessment is fully independent and based on the necessary expertise.

– Simplified reporting procedures so that researchers no longer have to submit largely identical information on the clinical trial separately to various bodies and Member States.

– The possibility for the Commission to conduct controls in EU countries and third countries to make sure the rules are being properly supervised and enforced.

Finally, the new legislation will take the legal form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU. This is vital to ensure that Member States, in authorising and supervising the conduct of a clinical trial, base themselves on identical rules.

What role will Ethics Committees have under the new rules?”

… continues on the site

For more information on clinical trials in the EU:



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