The European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation comes into force today, the 31st of January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
Prior to the Regulation, clinical trial sponsors had to submit applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials. The Regulation also makes it more efficient for EU Member States to evaluate and authorise such applications together, via the Clinical Trials Information System. The purpose is to foster innovation and research in the EU, facilitating the conduct of larger clinical trials in multiple EU Member States/EEA countries. Other key benefits of the Regulation include:
- improving information-sharing and collective decision-making on clinical trials;
- increasing transparency of information on clinical trials;
- ensuring high standards of safety for all participants in EU clinical trials.
See the 22.1.2022 announcement on the EMA website at this link