Ensuring Medicines for Tomorrow’s World
Chapter 4: The Global Regulatory Environment: Quality, Safety and Efficacy
4. The global regulatory environment: quality, safety and efficacy The term ‘regulation’, as it relates to the drug field, has commonly been used in a relatively narrow sense, relating only to the process by which new drugs are evaluated to determine their eligibility for admission to the market. In fact the broad field of drug regulation involves many more layers of policy. In order to ensure that the way medicines are created and used serves society as well as possible, a series of mechanisms must be deployed, some of them regulatory in the narrow sense of assessing safety and efficacy, but also involving provision of information, education, persuasion and financial resources. The term ‘regulation’, with overtones of bureaucracy and deprivation of freedom, tends to arouse protest and opposition, and this reaction can serve a useful purpose. The more that can be achieved by developing a broad consensus in society regarding an optimal pattern of behavior rather than by imposing intrusive rules, the better. In practice, it has been possible in many cases to formulate rules on which there is such a broad measure of agreement that they do not have to be imposed upon the unwilling. That, after all, is precisely the way in which the community of nations, having no superior authority, has at its best always functioned, and that is the way in which a national society can hope to function. Yet it must be recognized that large economic interests are at stake in the field of medicines,...
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