MTaPS Pharmacovigilance Factsheet

PV is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other possible medicine-related problems. Adverse effects of medicines, particularly those that are unexpected, can negatively affect patients’ health and quality of life and further strain and undermine trust in the health care delivery system. PV is critical for determining the true safety and efficacy profile of a product in a given population once on the market, including identification of effects not necessarily seen in clinical trials.

USAID MTaPS supports LMICs to build or strengthen PV systems and develop capacity to generate, analyze, and use safety data to improve health outcomes and the quality of care using the WHO Global Benchmarking Tool (GBT) for regulatory systems as a guiding instrument.