Regulation in medicines: Making harmonisation work: the politics of Scientific expertise in European medicines regulation

摘要

European-wide harmonisation of regulation is medicines is more successful than previously because of political, bureaucratic and institu- tional 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 mu- tual recognition system involves national regu- latory agencies competing for regulatory work.