Promoting the Quality of Medicines Program Quarterly Report: Project Year 2016, Quarter 3: April - June 2016

The program aims to strengthen medicines regulatory authorities and quality assurance systems, as well as support the manufacture of quality-assured priority essential medicines for various health conditions. The PQM program provides technical assistance to 20 countries, two Regional Missions, and four core health programs. The program's work focuses on four key 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 result area, PQM provides technical assistance to strengthen pharmaceutical policies, legislations, and regulations to address critical quality assurance topics. Highlights during the third quarter of FY16 include the timely registration of 10 priority medicines by the Ethiopian Food, Medicine and HealthCare Administration and Control Authority (EFMHACA), including one antimalarial, five maternal, newborn, and child health (MNCH), and four HIV medicines. PQM supported EFMHACA to develop guidelines and risk-based approaches that made the timely registration possible. Significant progress was also achieved in the development of pharmaceutical law in Guinea and the Nigerian Ministry of Health implementation of the newly approved national Quality Assurance Policy. In Thailand, PQM worked closely with Thailand's Ministry of Public Health's Bureau of Vector-Borne Diseases Control at the policy level. Two key components of medicines quality (drug quality monitoring and the inspection of drug supply and distribution for control of artemisinin monotherapy) were included in the Operational Plan 2017-2021 of the National Malaria Elimination Strategy 2017-2026. The availability of quality medicines is the second result area, which encompasses PQM's broad technical assistance for the manufacturing of quality-assured priority essential medicines. PQM provides support to manufacturers to attain stringent international good manufacturing practices (GMP) standards necessary for the supply of quality medicines. Significant accomplishments from the quarter include the capacity-building workshop conducted for local manufacturers to help prepare for upcoming GMP audits and subsequent implementation of interventions. EFMHACA's target is to have five companies achieve GMP certification within the next five years. In Pakistan, PQM supported the Drug Regulatory Authority of Pakistan (DRAP) in the evaluation of a previously submitted dossier for local manufacture of chlorhexidine (CHX) gel for newborn umbilicus cord care. Also in Pakistan, full compendial analysis training on CHX was conducted for nine analysts from four manufacturers embarking in producing CHX gel products locally. Technical assistance to manufacturers in pursuit of WHO Prequalification or other stringent regulatory authorities was carried out for both the Core Tuberculosis (TB) program, which supported six priority multi-drug resistant tuberculosis (MDR-TB) products, and Core MNCH, which supported four priority products: two for maternal use, one for newborns, and one for children. Improving the capacity to detect poor-quality medical products is the third result area. In collaboration with a country's MRA and national health program, medicine testing is conducted at a variety of sites in an effort to continuously monitor the quality of medicines present in the country. Field staff are trained in sampling and testing methods while national laboratories handle samples requiring advanced confirmatory testing. During the quarter, the Core MNCH program developed quality control screening procedures for three penicillin products. In Pakistan, an introduction of inter-laboratory testing training on chlorhexidine gel was conducted to 10 analysts from eight federal and provincial government laboratories. The fourth result area is global advocacy and technical leadership to enable the use of product quality information for decision-making. Results included under the result area highlight PQM's contribution to advocacy efforts to eradicate falsified and substandard products through transparent sharing of data on quality of medicines and collaboration with diverse partners at local, national, and international levels to advance pharmaceutical quality agenda. PQM introduced the Poor-Quality Medicines ALERT, accessible via the Medicines Quality Database (MQDB) home page, to provide rapid access to information on poor-quality medicines identified in post marketing surveillance activities in PQM supported countries.