Board Decisions

GF/B20/DP13


Approved by the Board on:
11 November 2009


Quality Assurance Policy for Pharmaceutical Products

The Board recognizes that, as described in the Portfolio and Implementation Committee's Report to the Board (GF/B20/5), there are challenges with identifying sources for certain essential and long-established multi-source treatments that meet the requirements of the Global Fund's revised Quality Assurance Policy for Pharmaceutical Products ("QA Policy"). In order to avoid disruption to treatment of patients, but without compromising the fundamental quality assurance principles of the QA Policy, the Board therefore decides to revise the QA Policy to expand the eligibility criteria for a risk/benefit review of products by the Expert Review Panel (ERP) by adding the following interim provision at the end of paragraph 13 of the QA Policy:

"Provided that the criterion in paragraph (ii) above is met, certain multi-source [8] FPPs for malaria and first-line tuberculosis treatment that do not meet the criteria in paragraph (i) above are also eligible for review by the ERP for associated potential risks/benefits in accordance with paragraph 10 of this Policy. The list of ERP-recommended FPPs that is made publicly available will indicate which of the ERP-recommended FPPs were eligible for review as a result of this paragraph.

Footnote 8: For these purposes, "multi-source" means a pharmaceutical product for which the monograph of the finished dosage form was published in the International, U.S. or U.K. Pharmacopeia before 10 October 2002"

The Board requests the Market Dynamics and Commodities Committee to review this amendment to the QA Policy, with special attention to the working, transparency and reporting requirements of the ERP review process, and to report to the Board at its last meeting in 2010.

The Board notes that it will take some time for dossiers for these multi-source FPPs to be prepared and submitted to the next set of ERP reviews and that an interim exception is necessary to avoid disruption in essential treatment. The Board decides that, on an exceptional basis and for the period up to 31 December 2010 only, grant funds may be used to procure certain multi-source FPPs for malaria and first-line tuberculosis treatment, provided that:

a. there are no other FPPs for that product formulation available (as defined in the QA Policy) that are WHO-prequalified or SRA-authorized or ERP-recommended;

b. the site at which such FPP is being manufactured must, at the time of the procurement, be in compliance with the relevant GMP standards as verified by the WHO Prequalification Program, or an SRA or a regulatory authority participating in PIC/S;

c. the FPP has been selected for procurement by relevant UN procurement agencies; and

d. the notification/confirmation and testing processes described in paragraphs 9 and 31 of the QA Policy will apply to such procurement.

The Board requests the MDC to consider, as a matter of urgency, contingency plans regarding the recently notified disruption of funding for certain life-saving medicines (e.g. artemisinin intra-rectal and injectable medicines) in situations where no FPPs for such medicines meet the criteria in paragraph 7 of the QA Policy and to make recommendations to the Board at the earliest opportunity.


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