Overview

The Clinical Trials Directive has been highly criticised for contributing to a significant drop in the number of clinical trials conducted in the European Union (EU), with associated costs and the time taken to launch a trial almost doubling. To remedy these unintended consequences, the European Commission recently released proposals to amend the existing regulatory framework. The proposal for a new EU Regulation on clinical trials promises significant improvements to the current legal framework and is a clear attempt to streamline the rules in order to reduce the administrative burden and speed up time for the authorisation of new clinical trials.