The role and remit of regulatory authorities

The pharmaceutical industry is one of the most highly regulated industries known. Governments in virtually all world regions continue to pass tough laws to ensure that every aspect of pharmaceutical activity is tightly controlled. All regulations pertaining to the pharmaceutical industry are enforced by government-established regulatory agencies. The role and remit of some of the major world regulatory authorities is outlined below. In the context of this chapter, particular emphasis is placed upon their role with regard to the drug development process.

Table 4.6 The main product categories (and annual sales value) that the FDA regulate

US$500 billion worth of food

US$350 billion worth of medical devices

US$100 billion worth of drugs

US$50 billion worth of cosmetics and toiletries

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