WHO Model Risk Management Plan (RMP) Assessment Tools

The WHO Model RMP Assessment Tools comprise a guidance document, a standardized template, and a model SOP to support National Regulatory Authorities (NRAs) in conducting consistent, transparent, and risk-based evaluations of Risk Management Plans (RMPs). They are intended for regulators, pharmacovigilance assessors, and technical experts who review RMPs for medicines and vaccines throughout the product lifecycle. The tools aim to strengthen regulatory decision-making, enhance capacity for safety assessment and post-authorization monitoring, and facilitate reliance and collaborative reviews. The final version of this Assessment Tools will be made available following completion of the WHO internal editing and publication process.

WHO Model Guideline for RMP Assessment provides principles and methodological guidance for the structured review of RMPs.

Structured RMP Assessment Template is a practical assessment template that guides reviewers through the key elements of an RMP, including the safety profile, pharmacovigilance activities, and risk minimization measures. The template also includes guiding questions to facilitate the comprehensive and consistent evaluation of RMP components.