Based in Amsterdam, the European Medicines Agency evaluates medicines for the entire European Union. One application, one scientific review, and a single opinion on whether a drug can be marketed across member states. The EMA does not approve drugs itself. It recommends, and the European Commission makes the final decision. But the agency's scientific assessment carries the weight.

The EMA was established in 1995 to harmonize drug regulation across Europe. Before that, companies had to file separate applications in each country, a slow and expensive process. Today, the centralised procedure is mandatory for certain products, including biologics, orphan drugs, and advanced therapies. For others, companies can choose between centralised, decentralised, or mutual recognition routes. The EMA also coordinates pharmacovigilance across the EU, monitoring the safety of medicines after approval and taking action when new risks emerge.

What the EMA does:

• Scientific evaluation. Reviews data on quality, safety, and efficacy.
• Marketing authorization. Recommends approval to the European Commission.
• Pharmacovigilance. Monitors safety after authorization.
• Scientific advice. Guides companies during development.
• Inspections. Checks compliance with good manufacturing and clinical practices.

Brexit moved the EMA from London to Amsterdam. The agency now works with the UK's MHRA as a separate regulator.