WHO Global Benchmarking Tool

Regulatory systems strengthening has been hampered by the lack of any shared understanding of "what good looks like" and any agreed-upon metrics to assess national regulatory agencies (NRAs). As a result, less mature NRAs had no reliable process for improvement or for having their improvements be recognized in a systematic way.

With the Gates Foundation's support, the WHO developed the Global Benchmarking Tool (GBT) to provide a structure for effective regulatory systems strengthening work.

The tool includes a catalogue of approximately 300 indicators in nine major categories of regulatory responsibilities (e.g., laboratory testing, clinical trials, marketing authorization, market surveillance and control, pharmacovigilance, etc.). Using the GBT, the WHO can certify national regulatory agencies by Maturity Levels (ML) ranging from 1 to 4, with ML3 signifying an NRA functioning at the minimal level for local regulatory oversight. Maturity levels are assigned separately for medicines and for oversight of vaccine manufacturing. Currently a GBT for in vitro diagnostics and medical devices is being developed. There is also a GBT for ethics committees.

Given this framework, countries are empowered to conduct self-assessments, request a consultation from the WHO, and create a detailed Institutional Development Plan to achieve the next maturity level. When they feel they are ready, they request that the WHO perform a formal assessment using the GBT and assign an official maturity level to the NRA.

To determine if an agency is performing at a level to be a reference agency for WHO, for other regulatory agencies, and for procurement agencies, WHO developed the WHO Listed Authority (WLA) program. To be a WLA, an agency needs not only to reach ML4 from a technical capacity and capability perspective, but it also to demonstrate its ability to perform at that level over time. These "performance" indicators, in addition to the "technical" indicators of the GBT, are used to designate reference agencies.

The advent of the GBT and the ML accreditation system and the WLA program have initiated a cycle of continuous improvement among NRAs in low- and middle-income countries, with more countries achieving ML 3 or 4 status each year since the advent of the GBT in 2019. Now, some of those countries are working toward WLA status as well.

As of 2025, eight African regulators have achieved ML3 status (in either medicines or vaccines manufacturing, or in one case (Egypt) both), and in the next 3-5 years, we expect some of these to achieve ML4 status, and, hopefully soon thereafter, WLA, and additional countries to achieve ML3 status. China and India have achieved ML3 status in vaccine manufacturing and are now developing plans to achieve ML3 status in medicines. This is critical not only because these domestic markets serve billions of people but also because their thousands of manufacturers export vaccines and medicines to Africa and its 1.4 billion people.