MTaPS Experts Unpack the Benefits of the Game-Changing WHO Global Benchmarking Tool

Globally, national regulatory authorities (NRAs) play the critical role of assuring the quality, safety, and efficacy of medical products both before and after products enter the market. However, the World Health Organization (WHO) estimates that only 30% of NRAs among its member states have the capacity to effectively and efficiently regulate medical products in their countries. This is a challenge as regulatory systems are critical to provide the enabling foundation for achieving universal health coverage (UHC), a target of Sustainable Development Goal 3.

To support countries in strengthening their regulatory capacity, WHO developed a framework for measuring and improving regulatory systems – the Global Benchmarking Tool (GBT). The GBT is the first globally accepted tool for assessing and strengthening national regulatory authorities. In a newly published BMJ Global Health article, Javier Guzman, Erin O’Connell, Kate Kikule, and Tamara Hafner of the USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program elaborate on the tool’s benefits for countries and offer specific ideas for strengthening the GBT framework and process.

“The tool shifts the focus solely from scoring the system to actionable steps and strategic investments for strengthening regulatory systems,” assert the authors in calling the GBT tool a game-changer for all stakeholders—donors, countries, and the local and regional pharmaceutical manufacturing industries.

The MTaPS program supports regulatory work under the program’s objective of strengthening pharmaceutical sector governance. The strengthened structures will better oversee and enforce policies, laws, and regulations that can ensure access to quality-assured, safe, and effective medicines and protect patients from harm.
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