Which regulatory body oversees drug approvals in the European Union?

The European Medicines Agency (EMA) is the regulatory body responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. It plays a crucial role in the drug approval process within the EU by providing scientific advice, conducting assessments, and ultimately issuing authorizations for medicinal products.

The EMA's responsibilities include ensuring that drugs are effective and safe for public use before they can be marketed within EU member states. It also coordinates the evaluation procedures for centralized marketing authorizations, allowing a company to obtain a single marketing authorization that is valid in all EU countries.

While the FDA oversees drug approvals in the United States and the WHO provides guidance and sets international health standards, neither of these organizations governs the approval process specifically within the EU. The ICH works to harmonize regulations across different regions but is not a regulatory body that directly approves drugs. Thus, the EMA is definitively the correct answer when it comes to drug approvals in the European Union.