WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products

Book excerpt: This manual is intended to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans (IDPs) to address areas for improvement. The manual is integral to the World Health Organization’s structured and evidence-based approach to regulatory systems strengthening (RSS), mandated by World Health Assembly resolution WHA 67.20. The manual serves to ensure a proper understanding of the Global Benchmarking Tool (GBT); the processes and principles that govern its use; the expectations of individuals and institutions involved; and the information management systems that underpin the collection, analysis and management of data and the generation of knowledge.