Clinical trials in Europe

Clinical trial regulation in Europe is based on the EU Clinical Trials Regulation (536/2014), which is a single regulatory framework that applies to clinical trials conducted in all EU member states. The regulation aims to harmonize the regulation of clinical trials across the EU and to simplify the approval process for sponsors.

Under the EU Clinical Trials Regulation, the sponsor must obtain approval from the relevant regulatory authority and an ethics committee before conducting a clinical trial. The application for approval is submitted through the EU Clinical Trials Portal, which enables sponsors to apply for approval in multiple EU member states simultaneously.

The regulation also includes provisions for the transparency of clinical trial data, including requirements for sponsors to publish clinical trial results in a publicly accessible database.

The EU Clinical Trials Regulation will be fully applicable in 2022, replacing the previous Clinical Trials Directive (2001/20/EC). The new regulation includes several changes, such as streamlined application procedures, simplified reporting requirements, and increased transparency and patient participation in clinical trials.

Overall, the EU Clinical Trials Regulation provides a streamlined and harmonized regulatory framework for conducting clinical trials in Europe, with a focus on ensuring patient safety and promoting transparency in clinical research.