On 17 July 2012 the Commission adopted a proposal for a 'Clinical trials Regulation'.
Clinical trials are tests of medicines in humans. They give patients access to most innovative treatments and are vital to develop medicines and to improve and compare the use of already authorised medicines. Clinical trials, the backbone of clinical research, are crucial to save or improve the quality of many lives every year.
The proposed Regulation, once adopted, will replace the 'Clinical Trials Directive' of 2001. This Directive has already ensured a high level of patient safety, but its divergent transposition and application led to an unfavourable regulatory framework for clinical research, thus contributing to a decrease of 25% of clinical trials launched in the period between 2007 (more than 5 000) and 2011 (3 800).
The new legislation will take the form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU while maintaining the highest standards of patient safety and robustness and reliability of data.
In particular, it will make it easier to conduct multinational clinical trials in Europe. Some concrete proposals are:
• An authorisation 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.
It is foreseen that the new legislation will better benefit citizens and make sure that clinical trials are conducted to the highest standard across all EU Member States.
