PQM Support in Burma

PQM's primary objective is to strengthen the capacity of Burma's national system to improve and sustain quality assurance (QA) and quality control (QC) of medicines, as well as build regional cooperation. Prior to 2012, little was known about the quality of medicines in Burma. However, PQM conducted training workshops and analyzed available reports, which revealed several areas of concern within Burma's QA/QC systems. These areas include weak pre-market product evaluation for registration, inadequate quality management systems, and limited post-marketing surveillance. Additionally, the Food and Drug Administration's (FDA) quality control laboratories in Nai Pyi Taw and Mandalay lack sufficient equipment and trained personnel to perform compendial analyses. PQM has set several goals to address these challenges and build the capacity of national health programs in Burma. The first goal is to establish baseline data on medicines for priority diseases through a household and health facility survey using random sampling methodology. This will provide a foundation for future quality assurance and quality control efforts. The second goal is to establish a pilot medicines quality monitoring mechanism in collaboration with the World Health Organization country office. This mechanism will enable the early detection of poor-quality antimalarial and antibiotic medicines in targeted areas, supporting post-marketing surveillance activities by the FDA and local health agencies. The third goal is to strengthen the technical capacity of the Nay Pyi Taw and Mandalay quality control laboratories for medicines quality analysis meeting international standards. This will involve providing training and equipment to laboratory personnel to ensure they can perform compendial analyses accurately. The fourth and final goal is to engage the FDA in a regional initiative on technical expertise, information-sharing, and action-taking on counterfeit medicines. This will facilitate collaboration and knowledge-sharing among regional stakeholders to combat the issue of counterfeit medicines. The PQM initiative in Burma is a critical step towards improving the quality of medicines in the country. By addressing the identified areas of concern and building the capacity of national health programs, PQM aims to ensure that medicines are safe, effective, and accessible to those who need them.