Strengthening medicines regulatory systems

Bolstering national and regional authorities to improve access to medicines

Strong regulatory systems are fundamental to resilient health systems. Medicines regulatory authorities (MRAs) help people access safe, effective, and quality-assured medical products and guard against harmful substandard and falsified ones. With effective oversight and greater efficiency, MRAs can help ensure quality medicines reach patients faster and foster an enabling environment for expanded regional and local manufacturing.

We work to support national MRAs to strengthen regulatory functions and achieve advanced regulatory maturity so that they may serve as a key link in the medicine supply chain, protecting consumers from poor-quality medicines, promoting global health security, and improving health equity.

Supporting regulators during COVID-19

COVID-19 revealed long-standing vulnerabilities in health systems and pharmaceutical supply chains, particularly in low- and middle-income countries. To support regulators in responding to the pandemic, we issued a pandemic preparedness paper and, through the USAID-funded PQM+ program, issued guidance for streamlined emergency use authorization procedures for vaccines and diagnostics.

Resources

Proposed Models to Build Capacity for Emergency Use Authorization for Vaccines and Diagnostics
Supporting the global health response to COVID-19
Webinar slides: Unpacking medical regulatory systems, Nov 2020 (PDF)
Technical paper: Strengthening regulatory systems, Sept 2018 (PDF)

two women in protective suites looking at clipboards in a lab

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