TRS 1033 - Annex 10: Good reliance practices in the regulation of medical products: high level principles and considerations

Annex 10, WHO Technical Report Series, No.1033, 2021

Overview

WHO supports reliance on the work of other regulators as a general principle in order to make the best use of available resources and expertise. This principle allows leveraging the output of others whenever possible while placing a greater focus at national level on value-added regulatory activities that cannot be undertaken by other authorities, such as, but not limited to: vigilance, market surveillance, and oversight of local manufacturing and distribution. Reliance facilitates timely access to safe,  effective, quality-assured medical products and can support regulatory preparedness and response, particularly during public health emergencies.
WHO Team
Access to Medicines and Health Products (MHP), Health Product Policy and Standards (HPS), Norms and Standards for Pharmaceuticals (NSP), Technical Standards and Specifications (TSS)