Ensuring Quality, Safety and Efficacy

Publisher Summary Medicines might largely be avoided if enough evidence of quality, safety, and efficacy are not provided by the manufacturer prior to their introduction. A concurrent problem is the fact that the standards prescribed by the law—which calls for quality, efficacy, and safety—are not as exact as they appear on paper. If the quality standards are set too low, the medicine may be ineffective or dangerous, whereas if too much is demanded, the work of making the medicine and checking the quality of every batch may be so laborious as to render it unaffordable. In various parts of the world, there is a considerable market of spurious and counterfeit products, many of which are of extremely poor quality. A product should clearly have the type of pharmacological effect and the potency that it claims, explicitly or by obvious implication, to possess; a product sold as an antibiotic or a corticosteroid must possess these properties to a clinically significant degree.