Improving patient safety for better health outcomes
Strengthening pharmacovigilance programs to detect and prevent adverse drug events and reactions
Assuring the safety of medicines and health products doesn’t stop once they’re approved for market use. Monitoring and surveillance of a product’s safety – also known as pharmacovigilance – is important in detecting rare and serious side effects that may not be observed in clinical trials.
Effective pharmacovigilance programs are critical to strong regulatory systems and support effective regulatory responses that protect patients from potential harm. We work to strengthen pharmacovigilance programs to ensure the continued safety of medicines, vaccines, and other medical products; optimize treatment regimens; and support data-driven decision making.
Reporting adverse events for COVID-19 medical products
With the increasing availability of COVID-19 vaccines and treatments comes an equally urgent need for surveillance systems to monitor their continued safety. Through the Promoting the Quality of Medicines Plus (PQM+) program, funded by the U.S. Agency of International Development (USAID), we’re working with national medicines regulators in Burkina Faso, Ethiopia, Ghana, Kazakhstan, Pakistan, and Uzbekistan to improve pharmacovigilance and ensure safe, effective, quality vaccines for patients.

Resources
- Risk-based post-marketing surveillance of medicines (Oct 2021, PDF in EN and ES)
- Accelerating the Rollout of COVID-19 Vaccines: A How-to Guide for National Regulatory Authorities in Low- and Middle-Income Countries (Dec 2020)
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