GF/B16/DP17
Approved by the Board on: 13 November 2007
Interim Quality Assurance Policy for Multi-Source Products
The Board requests the Portfolio Committee to conduct a review of the Global Fund's quality assurance policy for drugs, taking into account alignment with relevant partners' quality assurance policies, concerns about safety, stability and efficacy of drugs, and market dynamics, and report back to the Board at its Eighteenth Meeting.
Concerns have been raised about the risk of quality assurance problems with drugs previously covered by the Global Fund's Quality Assurance Policy for Single and Limited Source Products ("Single Source QA Policy") that have recently been re-categorized as multi-source products (GF/B16/7 Revision 1). As an interim measure to address this risk pending the outcome of the review of quality assurance policy, the Board decides that any drugs for the treatment of HIV/AIDS, TB and malaria for which the formula has been published since the Third Board Meeting (10 October 2002) shall be subject to the Single Source QA Policy.