What is European Medicines Agency (EMA)

European Medicines Agency (EMA) is a centralized government body whose goal is to promote and protect human and animal health through overseeing the use of medications in European countries. The EMA, formerly called the European Agency for the Evaluation of Medicinal Products, is the European Union’s equivalent to the U.S. Food and Drug Administration (FDA). The EMA is sometimes called the European Medicines Evaluation Agency or EMEA, although this is not its official name.

BREAKING DOWN European Medicines Agency (EMA)

European Medicines Agency (EMA) originated in London in 1995. It serves a population of more than 500 million people in the European Union. The EMA’s mission is to protect the health and well-being of both people and animals living throughout the 28 EU member states, along with those in the countries located in the European Economic Area, or EEA. One of the agency’s primary priorities is to provide critical new medications to the patients who need them in a timely manner.

EMA’s role in medication approval

When a pharmaceutical company wants permission to sell a drug in certain parts of the world, it must get permission first from the EMA. If the EMA grants approval, the drug can be used throughout the European Union and in Iceland, Norway and Liechtenstein. The EMA also monitors the safety of medicines after they have been approved, through a process called pharmacovigilance. Further, the EMA inspects clinics and labs to make sure medicines are being tested and produced correctly. The EMA is not involved in research and development (R&D), nor is it involved in clinical trials.

The Food and Drug Administration and EMA collaborate through “clusters” to share safety information on issues such as medicine safety, biosimilars, cancer medicines, orphan medicines used to treat rare diseases, medicines for children and blood-based products. While the EMA and FDA are similar, they do not always approve the same drugs, and the EMA is perceived as being less strict than the FDA in its approval process, meaning that some drugs are approved in Europe that are not approved in the United States. Also, the EMA does not approve all drugs that are used in EU countries; individual countries may choose to approve drugs that the EMA has not approved.

The EMA does not decide whether a medicine can be marketed, and it does not develop or change drug laws, or directly influence medicines’ prices or availability. It is the European Commission that actually approves, denies, suspends or revokes marketing authorizations. The EMA’s role is to scientifically evaluate marketing authorizations for medicines.