The Global Benchmarking Tool: Lessons Learned Strengthening National Medicines Regulatory Systems




Session Date: April 22, 2021

Session Description: National regulatory authorities (NRAs) are critical for ensuring access to quality-assured medical products, however only 30% are estimated to effectively regulate medical products. The World Health Organization’s Global Benchmarking Tool (GBT) is the first globally accepted tool for objectively assessing regulatory capacity for medicines and vaccines—hence a game changer for regulatory systems strengthening. This panel will focus on the importance of strong regulatory systems, introduce the GBT, and illustrate its deployment in Bangladesh and Rwanda. In Bangladesh and Rwanda, MTaPS provides technical assistance to NRAs in regulatory systems strengthening, focusing on key functions that align with each country’s GBT assessment findings, specifically marketing authorization, pharmacovigilance (PV), licensing establishments, and regulatory inspections. To date, MTaPS has supported updating both countries’ strategic plans; developing national PV implementation plans; deploying efficient medicines registration processes, while adhering to good review practices; increasing health facility capacity in patient safety monitoring and building NRA institutional capacity to analyze and use patient safety data. In Bangladesh, MTaPS assisted the development of a pharmacy inspection and licensing system to increase regulatory efficiency. In Rwanda, MTaPS supported drafting the legal and regulatory framework, enabling effective NRA operations, and establishing a Quality Management System to standardize key regulatory functions.