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

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Report Type Reports and Testimonies
Report Date April 5, 1996
Report No. HEHS-96-71
Subject
Summary:

With a population of 370 million, the European Union (EU) represents a consumer base that is one-third larger than that of the United States. Moreover, the EU leads the world in the consumption of pharmaceutical products--nearly $83 billion worth in 1992. The EU recently changed its drug approval procedures and created a new agency--the European Medicines Evaluation Agency--to approve drugs more quickly and efficiently. Advocates of reforming the Food and Drug Administration (FDA) have suggested that the new European model may provide helpful lessons for improving the timeliness of FDA drug approvals. This report (1) determines how the EU now reviews and approves new drug applications and (2) explains why the European Medicines Evaluation Agency was established, how it operates, and how it is financed. GAO notes that because the EU system has been up and running for only a year, it is too soon to know whether it will enable drug companies to more quickly market their products throughout Europe.

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