Council adopts new rules to boost clinical trials in the EU
The Council approved, on 14 April, the proposal for a regulation on clinical trials on medicinal products for human use adopted by the European Parliament on 2 April. The new legislation streamlines the rules on clinical trials across Europe with the objective of increasing the number of investigations of medicines in humans conducted in the EU, while maintaining the high standards of patient safety.
It should, for instance, enhance transparency, as pharmaceutical companies and academic researchers will be asked to publish detailed summaries of the trials they conduct in a publicly accessible EU database. The text provides for specific provisions for low-intervention clinical trials, clarifies the roles of ethics committees in the authorisation process and provides details on obtaining the enlightened consent of patients.Read more in the Council's press release:www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/142181.pdf
To access the proposed regulation:http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07...