The United States Pharmacopeial Convention (USP) announced today the availability of a free, online collection of voluntary public standards to allow testing of a medicine and its ingredients to ensure that medicines and their ingredients used around the world are of good quality. These standards appear in the new USP Medicines Compendium (MC).
The MC will support good quality medicines through tests, procedures, and acceptance criteria for critical quality attributes. Published by USP and available at www.usp-mc.org, the MC will include standards for medicines legally marketed in various countries. Initially, the MC will include 10 standards proposed for public comment, and another 11 standards proposed for development.
“Public standards help ensure that all manufacturers of a given medicine or ingredient meet the same fundamental requirements, providing a ‘common ground’ that allows practitioners to have confidence in the medicines they prescribe, and patients in the medicines they take. These standards are critical—especially where regulatory resources are constrained or absent,” said Roger L Williams, MD, chief executive officer of USP. “The USP Medicines Compendium will be offered freely to all, so that it can be used by anyone—not just manufacturers, but purchasers, regulatory agencies and other pharmacopoeias as well, as a means of helping to ensure high-quality medicines. As the only non-governmental pharmacopoeia in the world, USP is in a special position to develop this compendium—a manifestation of the organization’s global public health mission” he added.
The first group of standards posted today includes those for anti-malarial, anti-retroviral (HIV), and contraceptive medicines, among others. For some of the medicines to be included in the MC, no other public standard may currently exist in any pharmacopoeia. MC is designed to address such public health gaps.
MC standards are voluntary, unless they are adopted by a regulatory authority. They are intended to support the text and work of other pharmacopoeias, and not to supplant it. MC standards may be especially useful for manufacturers who export to countries with scarce regulatory resources and no national pharmacopoeia.
USP expects the MC standards to become authorized and final approval by the USP Council of Experts in 2011. The written standards, or monographs, included in the MC utilize a novel scientific approach that differs from any other pharmacopoeia. MC standards are Performance Based Monographs (PBMs).
MC standards can include a posting of validation data relied upon to set the standards; this type of disclosure is a special feature of the MC. USP will offer reference materials for monograph tests where needed. MC standards are created in an open, transparent process similar to that utilized for USP's other compendia. Standards proposed for inclusion in the MC are available for public review by any interested party for a 90-day comment period before becoming authorized by the MC Expert Committee.