WHO Model Risk Management Plan (RMP) Assessment Tools
Regulatory pharmacovigilance
31 March 2026
| Guidance
Overview
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.
Components of the WHO Model RMP Assessment Tools
The WHO Model RMP Assessment Tools include a guideline, assessment template, and a model SOP for NRAs to use:
- WHO Model Guideline for RMP Assessment
Provides principles and methodological guidance for the structured review of RMPs. - Structured RMP Assessment Template
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. - Standard Operating Procedure (SOP)
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 model SOP can be found in a separate document.
WHO Team
Pharmacovigilance (PVG)
Number of pages
71