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.