The application of the clinical trial regulations has been postponed due to technical issues of the IT systems. Because of this, the EU Clinical Trial Regulation will not go into effect until 2019.
The ultimate goal of the new system is to provide a single-entry port for clinical trial submissions in addition to maintenance of applications and authorizations. Furthermore, there will be a better source of public information on clinical trials conducted in Europe.
“This is the most ambitious IT system required by the EU legislation in the last decade, involving a complete EU-wide system to be used for clinical trial applications, urgent safety measures and other notifications to regulators before, during and after the conduct of clinical trials,” the European Medicines Agency (EMA) stated.1
Key benefits of the regulation include:
- Harmonized electronic submission and assessment process for clinical trials conducted in multiple Member States
- Improved collaboration, information-sharing and decision-making between and within Member States
- Increased transparency of information on clinical trials
- Highest standards of safety for all participants in EU clinical trials
To see more highlights on the June 2017 EMA meeting click here. Pearl IRB’s AAHRPP accredited independent review board can support all U.S. based studies. Learn more about our variety of IRB services including single and multi-site/central IRB reviews for your next study.