Public standards are critically important, especially where regulatory and compendial resources are constrained or absent. The USP Medicines Compendium (MC) represents a novel approach to bring good public standards—monographs with reference materials—into the public domain as early as possible after access in a national market. Reliance on these standards can occur at the time of approval through regulatory decision-making and allows marketplace surveillance by manufacturers, purchasers, and the regulatory authority itself. Without the public monograph, some regulatory agencies may need to conduct the same kind of review that is accomplished independently by the USP Council of Experts. The MC thus reinforces the use of good quality standards by ethical manufacturers and can conserve scarce regulatory resources. The MC can become one of a series of safety nets that help combat counterfeit and substandard medicines. Read more. The MC is offered online only and is freely available for use by any interested party. |