Regulatory Inspections: EMA (European Union)

The European Medicines Agency (EMA) is the decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines for both human and veterinary use throughout the EU and the European Economic Area. The EMA’s primary role is to protect and promote public and animal health by ensuring that medicines available in the EU market are safe, effective, and of high quality. This is achieved through scientific evaluation of marketing authorization applications, ongoing pharmacovigilance (safety monitoring), and the establishment of robust regulatory standards.