The competent authority for GMO issues is the Malta Environment and Planning Authority (MEPA). No gene therapy applications have been submitted yet. Upon receiving an application by MEPA, the Biosafety Coordinating Committee (BCC) is informed. The main function of the BCC is to advise The Malta Environment and Planning Authority (MEPA) and the Minister responsible for Rural Affairs and the Environment on environmental implications of GMOs.
The Medicines Authority is also consulted as it is the competent authority for clinical trials. To conduct a clinical trial, one must submit applications with both the Medicines Authority and Ethics Committee, and an authorization by the Medicines Authority and a positive opinion by the Ethics Committee are required.
National authorities involved
Questions on the conduct of a clinical trial with a gene therapy medicinal product in Malta can submitted to:
(Last reviewed by the Competent Authority: December 2017)