Clinical Trials

The clinical trials conducted within the Center for Drug Evaluation are previously approved by the National Agency for Medicines and Medical Devices and by the National Bioethics Commission for Medicines and Medical Devices.

The Ethics Commission guarantees that the clinical trials conducted observe the ethical principles in Directive 2001/20/EC and the Declaration of Helsinki, the main focus of the activity of this committee being to protect the rights of subjects involved in clinical trials by assessing research proposals and making recommendations relating to the protection of human subjects.