WHO Model RMP Standard Operating Procedure (SOP)

Overview

A model SOP is included to support NRAs in establishing standardized procedures for the assessment of RMPs. The SOP outlines the roles and responsibilities of reviewers, key steps in the RMP assessment process, documentation and reporting requirements, and mechanisms for regulatory decision-making and follow-up actions. The final version of this Assessment Tools will be made available following completion of the WHO internal editing and publication process.

WHO Team
Pharmacovigilance (PVG)
Number of pages
4