The World Health Organization (WHO) began assessing regulatory systems in 1997, using a set of indicators designed to analyze regulatory programs for vaccines. Several tools and revisions were later introduced. The WHO Global Benchmarking Tool for evaluation of national regulatory systems of medical products (Revision VI) replaces all the tools previously used by WHO for evaluating regulatory systems.
The purpose of the tool is to evaluate the overarching regulatory framework and the regulatory functions that compose it: national regulatory system, registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, and NRA lot release, through a series of sub-indicators that may also be grouped and examined according to nine cross-cutting categories, for example, quality and risk management system.