Glossary
European Medicines Agency (EMA)
What is the European Medicines Agency (EMA)?
The European Medicines Agency (EMA) is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. It was established in 1995 and is headquartered in Amsterdam, Netherlands.
What are the main responsibilities of the EMA?
The EMA’s main responsibilities are to protect public and animal health by ensuring that all medicines available on the EU market are safe, effective, and of high quality. It evaluates applications for marketing authorizations, monitors the safety of medicines, and provides information to healthcare professionals and patients.
How does EMA evaluate and authorize medicines?
The European Medicines Agency (EMA) evaluates applications for marketing authorizations through the centralized procedure. All medicines derived from biotechnology, intended for certain diseases, or designated as orphan medicines must be approved via this procedure. The EMA’s scientific committees assess the medicine’s quality, safety, and efficacy before making a recommendation.
How does EMA monitor the safety of medicines?
EMA continuously monitors the safety of authorized medicines through a pharmacovigilance network. It takes appropriate actions if adverse drug reaction reports suggest changes to the benefit-risk balance of a medicinal product. For veterinary medicines, the EMA establishes safe limits for residues in food.
What is the role of the EMA in facilitating access to new medicines?
The European Medicines Agency (EMA) is committed to enabling timely patient access to new medicines. It uses various regulatory mechanisms to support medicine development and promote innovation in the pharmaceutical sector.
