WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Medical Products - Revision VI

Overview

The World Health Organization (WHO) considers medical products and other health technologies one of the six building blocks of health systems. Unlike many other commodities, however, end users and health care workers are typically not in a position to judge the quality of medical products. It is therefore essential that the interests and safety of the public be entrusted to a regulatory body responsible for ensuring the quality, safety, and efficacy of medical products throughout the product life cycle.

Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products. Effective, efficient and transparent regulatory systems are consequently an essential component of overall health systems and contribute to desired public health outcomes and to innovation and investment. In contrast, inefficient regulatory systems can be a barrier to access of safe, effective and quality medical products.