Competent Authority [CA]

Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths - the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.

Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.

HTA systems in Europe differ, but usually involve assessment and appraisal steps.

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or negative opinion. This is to ascertain that the research is conducted in compliance with European regulations, directives and guidelines defined by the International Conference on Harmonisation. This is an international quality standard that describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.