FAQs

The main aim of the Directive is to simplify and harmonise the administrative provisions governing clinical trials by establishing a clear, transparent procedure and creating conditions conducive to the effective co-ordination of such clinical trials in the European Community by the authorities concerned. This would facilitate the internal market in medicinal products while at the same time maintain appropriate levels of protection for public health. Overall, the Directive aims to provide an environment for conducting clinical research that protects participants without hampering the discovery of new essential medicines.