Industry news

Clinical Trials Regulation Proposal

In July 2012 the Commission published a “Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”. As this title suggests this new Clinical Trials Regulation is intended to replace the CT Directive 2001/20/EC.

This change is being driven by the fact that the CT Directive has led to a decline of 25% in the number of clinical trials conducted in the EU between 2007 and 2011.

In a question and answer document published alongside the proposed Regulation, the Commission stated that they are “proposing new legislation to cut red-tape and bring patient oriented research back to Europe. The objective is to restore the European Union’s competitiveness in clinical research and the development of new and innovative treatments and medicines for the ultimate benefit of patients”.

The main changes proposed include:

• A simplified 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 Member State to appoint the body or bodies in charge of the assessment, on the condition that the assessment is fully independent and based on the necessary expertise.

• Regulatory Authorities in EU countries will work together and be held to the same timeframe when approving clinical trials

• Simplified reporting procedures which spare researchers from submitting largely identical information on the clinical trial separately to various bodies and Member States.

• 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.

• New rules for clinical trials that are conducted outside the EU but referred to in a clinical trial application within the EU. In these cases, the proposal provides for compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency.

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 in authorising and supervising the conduct of a clinical trial, Member States base themselves on identical rules.

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