Promoting the Quality of Medicines (PQM) FY 2016 First Quarter Report

Funded by the U.S. Agency for International Development (USAID), PQM is the successor to the Drug Quality and Information (DQI) program, implemented by the United States Pharmacopeial Convention (USP). The program achieves three main goals: building local capacity in medical quality-assurance systems, increasing the supply of medicines to USAID health programs, and ensuring the quality and safety of medicines globally. PQM provides technical assistance to developing countries, focusing on four intermediate result areas: national regulatory systems strengthened, availability of quality medicines increased, amount of substandard and falsified medicines and medical devices reduced, and global advocacy on medicines quality enhanced through technical leadership. The program operates in multiple regions, including Africa and the Middle East, Asia and the Commonwealth of Independent States, and Latin America and the Caribbean. In the FY16 first quarter, PQM made significant progress in strengthening medicines quality control. The program conducted 12 training workshops in 8 countries, provided equipment and supplies to 12 laboratories, and installed, calibrated, and qualified 50 laboratory instruments and equipment. Additionally, PQM assisted 42 companies in 14 countries in implementing Good Manufacturing Practices (GMP). The program also supported the testing of 1504 samples of antiretroviral, opportunistic infection, tuberculosis, antimalarial, and maternal and child health products. PQM's progress in the FY16 first quarter is highlighted in the following tables, which provide details on the program's accomplishments in quality control, quality management systems, medicines quality monitoring, and good manufacturing practices. The program's achievements in these areas demonstrate its commitment to ensuring the quality and safety of medicines globally. In terms of specific accomplishments, PQM provided equipment and supplies to 12 laboratories, installed, calibrated, and qualified 50 laboratory instruments and equipment, and assisted 42 companies in 14 countries in implementing GMP. The program also supported the testing of 1504 samples of antiretroviral, opportunistic infection, tuberculosis, antimalarial, and maternal and child health products. Furthermore, PQM prequalified one active pharmaceutical ingredient (API) and two finished pharmaceutical products (FPPs), and accepted two dossiers by the World Health Organization (WHO). Overall, PQM's progress in the FY16 first quarter demonstrates its commitment to ensuring the quality and safety of medicines globally. The program's achievements in strengthening medicines quality control, quality management systems, medicines quality monitoring, and good manufacturing practices are critical to addressing the critical issues related to poor quality medicines in developing countries.