Change on the Way for EU Clinical Trials Directive
Conducting a clinical drug trial in Europe is about to get a lot easier. That’s thanks to the “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” (“Clinical Trials Regulation”) – a measure adopted by the European Commission (EC) on July 17th.
The new regulation will supersede the controversial ‘Clinical Trials Directive’ of 2001, and eliminate much of the beauracracy that came to be associated with it. Specifically, the EC says this will ‘speed up and simplify the authorisation and reporting procedures, while maintaining the highest standards of patient safety and robustness and reliability of data.’
It is hoped that the change will boost the number of companies seeking to run clinical trials in Europe – a figure that saw a 25% decline between 2007 and 2011.
Click here for more information: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd