Making harmonisation work: The politics of scientific expertise in European medicines regulation

Graham Lewis and John Abraham

Science and Public Policy, 1998, vol. 25, issue 3, 155-169

Abstract: European-wide harmonisation of regulation in medicines is more successful than previously because of political, bureaucratic and institutional changes, which have induced regulators to compromise and reach consensus. It is being driven by a convergence of the institutional interests of national regulatory agencies and the industry in rapid drug approvals. This mutual recognition system involves national regulatory agencies competing for regulatory work. Mutual recognition extends peer review but may be less critical, because regulators may not have time to check thoroughly evaluations of other Member States. Furthermore, the compressed time frames of that peer review are leading to a diminished role for national expert science advisory committees, which traditionally have provided an important ‘independent’ form of peer review. Copyright , Beech Tree Publishing.

Date: 1998
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