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Challenges to the Legitimacy of International Regulation: the Case of Pharmaceuticals Standardisation

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Chapter Summary

In pharmaceuticals regulation the standardisation activities of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutical for Human use (ICH) is an interesting example of multilevel regulation. This chapter describes the regulatory activities of the ICH and deals with the evaluation of these activities in light of the requirements of legitimacy. In legal and social theory the notion of legitimacy connotes the acceptability and acceptance of collective action. Ideas about the acceptability of human action cover the normative aspects of legitimacy, while the conception of acceptance refers to empirical aspects. The necessity for international regulatory guidance with regard to pharmaceuticals was recognised in the 1980s, with the successful single market created by the European Community at that time setting an example of what could be achieved.

Keywords:ICH; international regulatory; multilevel regulation; pharmaceutical industry



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