Risk management plan (RMP) for introduction of new medicinal product (including vaccines)
The Committees were briefed on the outcomes of a gap analysis on use of an RMP in pharmacovigilance by 2 WHO regional offices. The challenges identified included the absence of legal requirements and lack of trained assessors with the capacity to evaluate RMPs for new vaccines. The WHO model RMP assessment tools were developed to enhance the technical capacity of regulators to evaluate RMPs. The tools, which include guidelines and templates, were used during a WHO RMP workshop held in May 2024 in Harare, Zimbabwe, where initial feedback was gathered from assessors representing various national regulatory authorities in the African Region. The RMP tools will be pilot-tested in selected countries and will be finalized for use in 2025. The Committees welcomed the WHO RMP tools, which would enhance countries’ capacity to review safety profiles and identify missing information for developing post-market safety monitoring plans, especially in low- and middle-income countries (LMICs).