Manual for benchmarking of the national regulatory system of medical products and formulation of institutional development plans

This manual was developed to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans to address areas for improvement.

The manual is integral to the structured and evidence-based approach of the World Health Organization (WHO) to regulatory systems strengthening as mandated by the 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.