Institutional and Individual Capacity Building in Pharmacovigilance
摘要
The Medicines, Technologies and Pharmaceutical Services (MTaPS) programme (2018–2025) was the fifth iteration of a series of US Agency for International Development (USAID)-funded programmes implemented by Management Sciences for Health (MSH) that have worked since the early 1990s to strengthen pharmaceutical systems to improve access to and appropriate use of safe, effective, quality-assured medical products and pharmaceutical services. Pharmacovigilance (PV) has been one of the core technical areas in these programmes with MTaPS and its predecessors having contributed to building PV capacity at global, regional, national, sub-national, and health facility levels in the public and private sector using a comprehensive system building approach. Given that the Global Benchmarking Tool (GBT) developed by the World Health Organization (WHO) is now the accepted global standard for objectively assessing national regulatory capacity for medicines and vaccines, MTaPS has structured its PV capacity building efforts around the six critical elements defined in the tool’s vigilance module. They include legal provisions, regulations, and guidelines required to define the PV regulatory framework; arrangements for effective organization and good governance; human resources; established and implemented procedures to effectively perform PV activities; mechanisms to monitor regulatory performance and outputs; and mechanisms to promote transparency, accountability, and communication [1]. MTaPS assisted five countries and three regional economic communities to strengthen their PV systems. MTaPS’ predecessor programme —the USAID Systems for Improved Access to Pharmaceuticals and Services (SIAPS) programme—supported PV capacity building in 12 countries.