European Medicines Agency (EMA)

The European Medicines Agency (EMA) is a decentralized body of the European Union (EU) that focuses on the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use within the EU. The EMA was established in 1995 and is now headquartered in Amsterdam, Netherlands, after relocating from London.

The EMA aims to ensure that medicinal products are safe, effective and of high quality. It operates independently through a network of experts across the EU and collaborates closely with national regulatory authorities in the EU member states. Additionally, the EMA works with international agencies and non-governmental organizations in areas of mutual interest. It operates several specialized networks and databases, which support various aspects of medicine regulation, from clinical trials and pharmacovigilance to quality control and real-world evidence generation. 

The agency’s primary functions include the scientific evaluation of marketing authorization applications for both human and veterinary medicines through a centralized procedure. The EMA’s Committee for Medicinal Products for Human Use and its veterinary counterpart, the Committee for Medicinal Products for Veterinary Use, play a key role in this process by issuing opinions that form the basis for the European Commission’s decision on whether to authorize a medicine. Once authorized, these medicines can be marketed throughout the EU and the European Economic Area (EEA).

In addition to its evaluation role, the EMA monitors the safety of authorized medicines through pharmacovigilance activities. The agency also provides scientific advice to pharmaceutical companies to support the development of new medicines. Other areas of focus for the EMA include orphan drugs for rare diseases, herbal medicinal products, pediatric medicines, and advanced therapies.