Europeanization of Medicines Regulation
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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. The process involves harmonization and mutual recognition of regulatory decision making across Member States as well as the transfer of some authority from Member States to supranational EU regulatory agencies. Our discussion draws on extensive documentary research and over 40 tape-recorded interviews with industrial scientists, regulatory affairs managers in industiy and governmental regulators in Germany, Sweden, the UK and the relevant EU organizations, conducted between 1994 and 1998. In particular we focus on the politics of scientific expertise within the Europeanization process and the implications of the latter for drug safety, public health and the democratic accountability of regulatory decision making.
KeywordsEuropean Union Member State Medicine Regulation Mutual Recognition Medicine Control Agency
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