What Is the European Medicines Agency (EMA)?
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. The EMA 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.
- The European Medicines Agency (EMA) is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
- The EMA serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein.
- The EMA practices pharmacovigilance to ensure the safety and efficacy of medicines.
- The EMA is not involved in clinical trials or R&D.
- Individual countries can choose to approve drugs that the EMA has not approved.
Understanding the European Medicines Agency (EMA)
The European Medicines Agency (EMA) originated in London in 1995. It serves a population of more than 500 million people in the EU. The EMA’s mission is to protect the health and well-being of both people and animals living throughout the 27 EU member states, along with those in the countries located in the European Economic Area (EEA).
It operates through four mission-critical task forces formed in March 2020. They are as follows:
- Digital Business Transformation: This task force is responsible for ensuring that the agency's initiatives are up to date as far as regulatory changes and digital initiatives are concerned.
- Regulatory Science and Innovation: This task force is responsible for translating key scientific and technological advances into regulatory language and governance that is of use to developers and small and medium enterprises (SME).
- Data Analytics and Methods: This task force issues expert scientific advice on products and authorization assessments and provides data analysis for products on the market.
- Clinical Studies and Manufacturing: This task force liaises with the agency's counterparts at the European Union and global level to support clinical trials and manufacturing.
One of the agency’s primary priorities is to provide critical new medications to patients who need them in a timely manner.
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, Iceland, Norway, and Liechtenstein. The EMA also monitors the safety of medicines after they have been approved, through a process called pharmacovigilance.
The EMA has established joint task forces with the heads of other medicine agencies to explore the costs and benefits and how to probably utilize big data.
The EMA defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” Medicine safety and efficacy is limited to results from clinical trials. This means that the medicine has been tested in a relatively small number of people and must be consistently monitored by healthcare providers throughout its use.
European Medicines Agency (EMA) vs. U.S. FDA
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 FDA and EMA collaborate through “clusters” to share safety information on issues such as medication safety, biosimilars, cancer medicines, orphan medicines used to treat rare diseases, medicines for children, and blood-based products. A biosimilar is a biological medicine very similar to another approved biological medicine. Biological medicine is medicine where the active ingredient is a living organism. Lantus is a good example of biomedicine. It is a man-made form of the insulin hormone.
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.