The Promoting the Quality of Medicines (PQM) program’s collaborative efforts help strengthen health systems, increase availability of quality-assured medicines, and prevent public exposures to poor-quality products, which is essential to optimizing health resources and improving health outcomes in low- and middle-income countries.
Fiscal Year (FY) 2016
|16 National regulatory systems strengthened with new procedures
National Regulatory Authorities in 16 countries enhanced their review and evaluation processes by adopting good pharmaceutical processes and strengthening their capacity to perform dossier review, registration of priority essential medicines, and inspection of pharmaceutical premises. This has helped countries to develop more effective regulation, which is critical to ensuring the quality of medical products and protecting people from exposure to falsified, substandard, and unapproved medicines.
|40 National laboratories increased capacity to test medicines quality
Official medicines control laboratories in 17 countries strengthened their quality management systems and enhanced their testing capabilities. These efforts resulted in 3 of these laboratories achieving ISO 17025 accreditation or reaccreditation status during FY 2016. These efforts help build more reliable health systems with quality surveillance programs that can effectively monitor and test medicines in circulation, and keep dangerous, poor-quality products off the market.
|51 Local manufacturers of essential medicines supported
Manufacturers in 9 countries built capacity to comply with international quality standards, and prepare dossiers to achieve World Health Organization (WHO) prequalification with PQM’s support. These efforts help scale up and increase availability of quality-assured, lifesaving medicines in areas of greatest need.
|12 Countries assisted with quality monitoring and surveillance
PQM provided support to medicines quality monitoring and post-marketing surveillance activities at 142 sites in 15 countries. Nearly 18,000 medicines from local markets have been collected and tested since these activities began. The results have been used to support hundreds of regulatory decisions and actions to remove poor-quality products from markets and blacklist suppliers. Detailed records of these results are available in the Medicines Quality Database.