The competent authority for GMO issues is the Malta Environment and Planning Authority (MEPA). No gene therapy applications have been submitted yet, although a guidance document for clinical trials is available. 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.
