A Risk-Based Resource Allocation Framework for Pharmaceutical Quality Assurance for Medicines Regulatory Authorities in Low- and Middle-Income Countries. June 2018
(2018; 30 pages)

Babigumira JB, Stergachis A, Kanyok TK, Evans L, Hajjou M, Nkansah PO, Pribluda V, Garrison LP, Nwokike JI. A Framework for Risk-Based Resource Allocation for Pharmaceutical Quality Assurance for Medicines Regulatory Authorities in Low- and Middle-Income Countries. USP: Rockville, MD. Submitted to USAID. June 2018.


Pharmaceutical quality assurance (QA) systems should include strategies for the identification of substandard and falsified medicines, vulnerabilities in the pharmaceutical QA system, and the proportional allocation of appropriate resources to mitigate or manage them. However, allocating adequate resources to build and strengthen pharmaceutical QA systems is a challenge for low- and middle-income countries (LMICs), many of which currently rely to some or a large degree on donor support that is not sustainable. This document proposes a framework for risk-based resource allocation for regulatory QA in LMICs to assist country regulatory agencies in managing and sustainably supporting pharmaceutical QA to achieve maximum health impact and efficiencies. This framework for a risk-based approach to resource allocation for pharmaceutical QA by medicines regulatory authorities (MRAs) is intended as a potential guide to the development of country-specific tools for resource allocation. The framework consists of six core elements: (1) risk analysis, (2) analysis of the pharmaceutical market, (3) analysis of the country characteristics, (4) assessment of the regulatory and QA environment, (5) risk management (including resource allocation for pharmaceutical QA), and (6) assessment of the impact of resource allocation. The framework can be operationalized by identifying: (1) risk-triggering and risk-mitigating factors using attributes of the country itself, (2) attributes of the regulatory and QA environment for medicines within the country, and (3) attributes of the country’s pharmaceutical market. Risk-triggering and risk-mitigating factors provide the basis for risk analysis, and risk analysis guides resource allocation. Finally, the impact of resource allocation is subject to impact evaluation. The framework will help countries to prioritize and channel limited resources to the most fundamental and high-impact regulatory functions. When deployed (assuming sufficient resources are available), the risk-based approach should help facilitate the progressive attainment of self-funded and potentially sustainable QA systems, maximizing country investments and enabling responsible graduation of countries away from dependence on donor support for regulatory systems strengthening. This risk-based approach for resource allocation for pharmaceutical QA at MRAs should help improve and maintain public health, achieve efficiencies, and promote public confidence in health systems.

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