Official regulation of medicines

This chapter describes the background to why it became necessary to regulate the use and supply of drugs, and the ways in which these processes are managed. • Basis for regulation: safety, efficacy, quality, supply • Present medicines regulatory system • Present day requirements • Counterfeit drugs • Appendix: the thalidomide disaster change the safety information e.g. add new warnings, or contraindications. The quality aspects may also need to be revised as manufacturing practices change. MAH's have strong profit motives for making claims about their drugs.

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