By John Abraham, Helen Lawton Smith (eds.)
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Extra info for Regulation of the Pharmaceutical Industry
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The formidable task of international harmonization would be aided through open engagement with critics and close attention to political cultures in different regions of the world. Notes I. The FDA was moved from the Department of Agriculture to the Federal Security Agency in 1940, then to the Department of Health, Education, and Welfare in 1953, before settling in the Department of Health and Human Services in 1979. Chapter 2 Europeanization of Medicines Regulation JOHN ABRAHAM AND GRAHAM LEWIS Introduction This chapter examines the Europeanization of medicines regulation across EU Member States, which is motivated by the goal of a single European market for pharmaceuticals.
This mutual recognition, known as the CPMP procedure, was a landmark in European medicines harmonization because it encouraged manufacturers to seek simultaneous marketing authorization for a drug (or new use of a drug) in five or more Member States, providing that they had an existing authorization for that drug (or new use of that drug) in at 42 Chapter 2 - Europeanization o/Medicines Regulation 43 least one Member State. If a company availed itself of this opportunity then the recipient Member States were obliged to take account of the original authorization.
Questions about the safety and efficacy of a drug thereby became inseparable from debates about clinical trials, just as in the United States. Unlike in America, however, the criterion that tests follow 'knowledge and methods currently available to medical science' was used less to mandate government control over a rigid methodology of double-blinded, Chapter 1 - Regulatory Laws and Political Culture in the US and Germany 31 clinically controlled trials than to grant official recognition to the professional authority of the BM.
