he new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is favourable for conducting clinical trials, and to encourage more sponsors to conduct trials across the European Union (EU) member states. The regulation will have a major impact on the conduct of clinical trials.

The Regulation will include:

• More harmonized and efficient clinical trial application procedures;
• Increased transparency regarding clinical trial data;
• Provisions that should be considered by sponsors to enhance safety and efficacy of drugs.

The implementation of 2001/20/EC Directive was an important step towards the harmonization of clinical trials in Europe, but as it was still subject to individual member state interpretations there were discrepancies in the laws between countries. This resulted in higher costs for sponsors and long trial start-up timelines. The number of newly registered clinical trials per year in Europe is declining in the past decade. The new ECTR aims to create a uniform framework for electronic clinical trial authorization and a centralized assessment of the application dossier. This will re... Read more