E-DRUG: A Risk-Based Resource Allocation Framework for Pharmaceutical Quality Assurance
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A Risk-Based Resource Allocation Framework for Pharmaceutical Quality Assurance for Medicines Regulatory Authorities in Low- and Middle-Income Countries
Allocating adequate resources to build and strengthen pharmaceutical quality assurance systems is a challenge for low- and middle-income countries (LMICs), many of which rely on donor support. A Risk-Based Resource Allocation Framework for Pharmaceutical Quality Assurance for Medicines Regulatory Authorities in Low- and Middle-Income Countries
proposes a framework to assist medicines regulatory authorities in LMICs in managing and sustainably supporting pharmaceutical quality assurance to achieve maximum health impact and efficiencies. The framework is specifically intended as a guide for the development of country-specific resource allocation tools, and consists of six core elements: (
(1) risk analysis,
(2) analysis of the pharmaceutical market,
(3) analysis of country characteristics,
(4) assessment of the regulatory and quality assurance environment,
(5) risk management, and
(6) assessment of the impact of resource allocation.
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Paul Crystal
USP
Paul Crystal <paul.crystal@USP.org>