Clinical Trials Directive: better regulation required now.

摘要

A harmonised, transparent, and evenly implemented regulatory framework for clinical trials throughout the EU is vital for the European bioscience industry to thrive. The Clinical Trials Directive 2001/20/EC was an important first step towards harmonising the requirements and processes in EU member states and should have created synergies and time savings. Instead, clinical trial sponsors face an increased bureaucratic burden, resulting from differences in the way the Directive has been implemented to accommodate national requirements. Neither scientific nor regulatory harmonisation has occurred, resulting in different regulatory standards being applied across Europe.