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European Union Drug Approval: Overview of New European Medicines Evaluation Agency and Approval Process

HEHS-96-71 Published: Apr 05, 1996. Publicly Released: Apr 05, 1996.
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Highlights

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.

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DrugsFood and drug lawForeign governmentsInternational cooperationInternational organizationsProduct evaluationProduct safetySafety regulationDrug approvalsPrescription drugs