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

Pharmacopeial Convention (USP) and funded by the United States Agency for International Development (USAID). The program aims to combat the proliferation of falsified and substandard medicines by building local capacity in medical quality-assurance systems, increasing the supply of quality medicines to USAID health programs, and ensuring the quality and safety of medicines globally. PQM provides technical assistance to developing countries to strengthen national medicine regulatory agencies, increase the availability of quality medicines, reduce the incidence of falsified, substandard, and unapproved medical products, and support quality medicines at the regional and global level. The program achieves these goals through four intermediate result areas: National Regulatory Systems Strengthened, Availability of Quality Medicines Increased, Incidence of Falsified, Substandard, and Unapproved Medical Products Reduced, and Actions Taken to Support Quality Medicines at Regional and Global Level Increased. During the second quarter of FY16, from January 1st to March 31st, 2016, PQM made significant progress towards its work plan objectives. In Indonesia, the Ministry of Health Regulation Number 02/2016 entitled "Guidelines for Sampling and Testing Medicines from Government/Public Facilities" was developed, facilitating cooperation between the Ministry of Health and the national medicines regulatory agency (BPOM) to ensure that public program medicines are routinely sampled and tested per government policy. PQM also provided support for the development of good practices guidance documents for international standard accreditation and trainings to strengthen regulatory workforce. In addition, PQM supported manufacturers to establish good manufacturing practices and develop quality-related documents necessary to achieve compliance with internationally accepted practices and prequalification programs, ensuring increased production of locally sourced and quality-assured medicines. PQM's work in the second quarter of FY16 focused on several key areas, including the strengthening of national medicine regulatory agencies, the increase in the availability of quality medicines, and the reduction of the incidence of falsified, substandard, and unapproved medical products. The program's progress was reported in an aggregate view of program achievements according to four intermediate result areas, followed by detailed portfolio level summaries of progress made towards work plan objectives. PQM's efforts in the second quarter of FY16 were led by the Agreement Officer's Representative Team, consisting of Mr. Anthony Boni, Pharmaceutical Management Specialist, Ms. Elisabeth Ludeman, Pharmaceutical Management Advisor, and Ms. Tobey Busch, Senior Pharmaceutical Management Advisor. The program's responsible staff included Jude Nwokike, Director, and other key personnel. PQM's work in the second quarter of FY16 was focused on several key regions, including Africa and the Middle East, Asia, Eastern Europe and Central Asia, and Latin America and the Caribbean. The program's progress in these regions was reported in detail, highlighting the achievements and challenges faced by the program in each region. Overall, PQM's progress in the second quarter of FY16 demonstrates the program's commitment to improving the quality of medicines in developing countries. The program's efforts to strengthen national medicine regulatory agencies, increase the availability of quality medicines, and reduce the incidence of falsified, substandard, and unapproved medical products are critical to ensuring the health and well-being of people around the world.