Promoting the Quality of Medicines Program: Inventory of Technical Resources

Agency for International Development (USAID) and the U.S. Pharmacopeial Convention (USP). The program aims to improve the quality of essential medicines in low- and middle-income countries (LMICs) to help prevent and treat various diseases, including HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, and threats to maternal, newborn, and child health. To achieve this goal, the PQM program supports the adoption of effective and enforceable policies and legislation, strengthens the regulatory and quality assurance workforce, and harnesses information to increase evidence-based decision-making. Through these activities, the program strengthens regulatory systems and improves the ability of manufacturers to produce quality-assured medicines. The PQM program has been providing technical assistance to governments and pharmaceutical manufacturers since 2009. During this time, it has developed or contributed to a significant number of resources that can be useful to implementers of medicines quality assurance programs and to decision makers who must consider the value of investments in medicines regulatory systems and quality manufacturing for LMICs. The program's primary technical areas include regulatory systems strengthening, manufacturing, laboratory strengthening, and quality surveillance. These areas are addressed through various resources, such as policies and guidelines, reports, success stories, fact sheets and briefs, journal articles, media articles, presentations, and videos. The PQM program's approach reflects a holistic view of medicines quality assurance, recognizing the dynamic and cross-cutting relationships among different aspects of the system. This approach aims to strengthen and improve the systems, structures, and processes that promote product quality. The program's resources are organized into four main chapters, each covering one of the primary technical areas. These chapters are preceded by a section of resources that introduce the project and its intervention zone, and are followed by a collection of resources that cut across multiple themes. The resources are grouped by type and displayed chronologically based on their publishing date in each grouping. The PQM program's inventory of technical resources provides easy access to these resources through a regularly updated document. The inventory includes a linked, alphabetical listing of the same resources, along with a URL and a citation to facilitate attribution by authors who quote or excerpt information therein.