On 29 May, the Public Health Committee in the European Parliament endorsed draft EU rules for clinical trials of new medicines
The new regulation is designed to encourage research while protecting patients’ rights and making simpler, more uniform rules. The new text makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients. It also simplifies reporting procedures and empowers the Commission to conduct checks. Finally, it stipulates that member states must respond to applications from clinical trial sponsors within fixed deadlines.