Which regulatory body governs the approval of pharmaceuticals in the European Union?

The European Medicines Agency (EMA) is the regulatory body responsible for the scientific evaluation and supervision of medicines in the European Union. It plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products throughout their lifecycle. The EMA’s functions include coordinating the evaluation of medicinal products across EU member states, providing scientific advice and support, and monitoring the safety of medicines once they are on the market.

The agency works closely with national authorities in the EU to facilitate a centralized approval process that allows companies to apply for a single marketing authorization valid in all EU countries. This streamlined approach is especially beneficial for companies seeking to launch their products across multiple markets within the EU, making the EMA a central figure in the regulation of pharmaceuticals in Europe.

Other organizations mentioned, such as the FDA, primarily govern pharmaceuticals in the United States; the WHO focuses on international public health and setting global health standards rather than direct pharmaceutical approvals, and Health Canada regulates medications within Canada.