Promoting the Quality of Medicines Program Fourth Quarter Report FY 2016

The program aims to strengthen medicines regulatory authorities and quality assurance systems in partner countries. As of September 2016, USAID supports PQM's work in 20 countries, two Regional Missions, one Cross Bureau program, and four core health programs. The program focuses on four Intermediate Result areas: strengthening national regulatory systems, increasing the availability of quality medicines, improving the capacity to detect poor-quality medical products, and increasing the use of information for decision making. In the first quarter of FY16, PQM provided technical assistance to strengthen national regulatory systems in partner countries. This included developing national laws and strategic plans, improving the effectiveness of medicines registration systems, and contributing to university-level pharmacy curricula. In Mozambique, a review of the pharmaceutical law resulted in recommendations for new regulations to strengthen the capacity for medicines quality assurance. PQM also conducted a regulatory quality assurance and quality control systems gap assessment in Bangladesh, which served as a foundational document for the National Health Sector Plan (2016-2024). In the Philippines, PQM developed terms of reference for a consultancy to incorporate quality assurance and quality control components into the development of the regulatory authority's strategic plan (2017-2021). The second Intermediate Result area focuses on increasing the availability of quality medicines. PQM provides technical assistance to manufacturers to comply with Good Manufacturing Practices (GMPs) necessary for the supply of quality medicines. During the quarter, technical assistance was provided to 46 manufacturers of priority medicines, including support for WHO Prequalification of the TB drug Rifampicin. PQM also supported the revision of Indonesia's regulation, known as 'Menkes 33/2016,' to ensure coordination between the ministry of health and regulatory authority on results stemming from post-marketing surveillance. The third Intermediate Result area aims to improve the capacity to detect poor-quality medical products. PQM conducts field testing in partner countries to continuously monitor the quality of medicines present in the country. During the quarter, samples were collected and tested in the majority of PQM-supported countries. In Ethiopia's medical device laboratory, an alarmingly high number of condoms failed quality tests (39/60 batches). The manufacturer has accepted the results, and all of the 141 total imported batches, worth approximately $2 million, have been banned from distribution. The fourth Intermediate Result area focuses on global advocacy and technical leadership to enable the use of product quality information for decision making. PQM participated in various workshops and meetings on topics related to TB eradication, detection tools, and competency for pharmacists. In Indonesia, PQM's monitoring efforts resulted in a Food and Drug Agency advisory to healthcare professionals and the public regarding poor-quality Isoniazid TB medication. PQM also documented new reports on global incidents of poor-quality medicines and shared the results on the PQM website. The PQM program has made significant progress in strengthening national regulatory systems, increasing the availability of quality medicines, improving the capacity to detect poor-quality medical products, and increasing the use of information for decision making. The program has also faced several challenges, including challenges in implementing quality assurance and quality control systems, and difficulties in detecting poor-quality medical products. Lessons learned from the program include the importance of building strong partnerships with regulatory authorities and manufacturers, and the need for continuous monitoring and evaluation of the quality of medicines in partner countries.