European Union Drug Approval:

Overview of New European Medicines Evaluation Agency and Approval Process

HEHS-96-71: Published: Apr 5, 1996. Publicly Released: Apr 5, 1996.

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Pursuant to a congressional request, GAO reviewed: (1) the new European Union (EU) procedures for approving new drug applications (NDA); and (2) why the European Medicines Evaluation Agency (EMEA) was established, how it operates, and how it is financed.

GAO found that: (1) because member states did not always accept EU or other members' drug approvals, the EU Commission of European Communities makes decisions on drug approvals and dispute resolutions that are binding on all members; (2) EU has also established new approval procedures for biotechnology, other high-technology, and innovative products; (3) regulating drug prices and reimbursement policies remains the responsibility of member states; (4) the centralized approval procedure for biotechnology and some innovative products is expected to take between 298 and 448 days; (5) the decentralized procedure allows manufacturers to seek approval from member states and appeal denied approvals; (6) the decentralized procedure is expected to take between 300 and 686 days; (7) industry officials are concerned about drug evaluators' qualifications and whether EU-wide interests will be upheld over national interests; (8) EMEA is responsible for the timeliness and coordination of new drug approvals, administrative duties, ensuring that drugs meet the highest standards of safety, efficacy, and quality, and maintaining information on the drugs and their adverse reactions; (9) the Commission and industry application fees fund EMEA, which has a small permanent staff and 2 scientific evaluation committees that draw on EU-wide scientific expertise; and (10) EMEA also provides advice to companies on their trial procedures and other matters.

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