Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products. Effective regulatory systems are an essential component of health systems and contribute to desired public health outcomes and innovation.

The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products. The tool and benchmarking methodology enables WHO and regulatory authorities to:

• identify strengths and areas for improvement;
• facilitate the formulation of an institutional development plan (IDP) to build upon strengths and address the identified gaps;
• prioritize IDP interventions; and
• monitor progress and achievements.

WHO began assessing regulatory systems in 1997 using a set of indicators designed to evaluate the regulatory programme for vaccines. Since that time, a number of tools and revisions were introduced. In 2014 work began on the development of a unified tool for evaluation of medicines and vaccines regulatory programmes following a mapping of existing tools in use within and external to WHO.

The development of the current GBT takes into consideration input received from two international consultations with Member States in 2015, a public consultation in early 2018 and a series of meetings involving experts from regulatory authorities from different parts of the world.

The GBT replaces all tools previously used by WHO, representing the first truly ‘global’ tool for benchmarking regulatory systems. The GBT is designed to evaluate the overarching regulatory framework and the component regulatory functions (e.g. clinical trial oversight) through a series of sub-indicators that may also be grouped and examined according to nine cross-cutting categories or themes, for example, quality and risk management system. Fact sheets have been developed for each sub-indicator to guide the benchmarking team and ensure consistency in the evaluation, documentation and rating of the sub-indicator.

The GBT also incorporates the concept of ‘maturity level’ or ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 (existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement).

The GBT is designed to benchmark the regulatory programmes of a variety of product types, including medicines, vaccines, blood products (including whole blood, blood component and plasma derived products) and medical devices (including in vitro diagnostics).  This is made possible by introducing supplemental criteria to a common set of criteria initially developed for medicines and vaccines in order to accommodate the specificities of blood products and medical devices e.g., hemovigilance for blood products; and risk-based classification/reclassification of medical devices.

A revised GBT user’s manual has also been published to ensure consistency in the planning and conduct of benchmarking.

The GBT and the relevant manuals are available in several official WHO languages   through the respective links on this page.

The GBT is supported by a computerized platform to facilitate the benchmarking, including the calculation of maturity levels. The computerized GBT (cGBT) is available, upon request, to Member States and organizations working with WHO under the Coalition of Interested Partners (CIP).