The European equivalent of the United States Food and Drug Administration (FDA) is the European Medicines Agency or EMA.
Though the core responsibility of the two bodies is to evaluate and approve medicines, they are different in one major way.
What is the European Medicines Agency (EMA)?
Established in 1995, the European Medicines Agency or Medicines Evaluation Agency is a regulatory body of the European Union (EU) that evaluates and approves all of Europe’s medicinal products.
Before the EMA was established, new medicines in Europe were assessed by the individual regulatory bodies of its different states. Winning the approval of so many states would cost drug companies an annual amount north of €300 million — a mammoth cost that would deter innovation.
Therefore, EMA was born, not to replace the bodies, but to harmonize them, and as a result making the process faster, more efficient, and more cost-effective.
Functions of the EMA
The EMA’s founding principle is the protection and promotion of human and animal health. It carries it out by assessing centrally authorized medicinal products for human and veterinary use and providing technical guidance and advice to its subjects.
Its workforce of more than 4000 is divided into seven committees, which supervise the regulation of their respective products.
- Committee for Medicinal Products for Human Use
- Committee for Medicinal Products for Veterinary Use
- Committee on Orphan Medicinal Products
- Committee on Herbal Medicinal Products
- Pediatric Committee
- Committee for Advanced Therapies
- Pharmacovigilance Risk Assessment Committee
How is the EMA different from the FDA?
The FDA is a centralized authority, while the EMA is a decentralized authority — a regulatory body that lacks a hierarchy.
In other words, its more than 4000 members spanning the EU do not fit neatly into a pyramid or any other hierarchy but form an open, transparent, though complex, network that works as a community to supervise products.
This allows the EMA to integrate and leverage medical expertise across a variety of fields.
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