Pharmaceutical products procured with Global Fund resources must adhere to Global Fund Quality Assurance Policy for Pharmaceutical Products, issued on 14 December 2010 and amended on 5 February 2014.
Antiretroviral, anti-TB and antimalarial pharmaceutical products
For the aforementioned pharmaceutical products to be eligible for purchase with Global Fund resources, there must be compliance with the quality standards set by the Global Fund Quality Assurance Policy. Global Fund grant monies may only be used to procure antiretroviral (ARV), anti-TB and antimalarial pharmaceutical products that are classified as Category A (WHO-prequalified) or Category B (authorized by stringent regulatory authorities or SRAs).
Note: Only International Conference on Harmonisation (ICH) members, observers or associated members are recognized as stringent regulatory authorities. Pharmaceutical Inspection Co-operation Scheme (PIC/S) members are not considered to be SRAs. ICH members, observers and associates include: the European Commission (EU), the European Free Trade Association (EFTA), Australia, Japan, Norway, Iceland, Liechtenstein and the United States. For a full list of member countries, please refer to the Global Fund Quality Assurance Policy. For medicines used exclusively by non-ICH members, positive opinions or tentative approval under any of the following three special regulatory schemes are recognized as stringent approval:
- Article 58 of European Union Regulation (EC) No. 726/2004.
- Canada S.C. 2004, c. 23 (Bill C-9) procedure.
- United States of America FDA tentative approval (for antiretrovirals under the PEPFAR programme).
However, if the Country Office (CO) determines that only one or no Category A or B manufacturer can supply a sufficient quantity of products within 90 days of an order being placed (or longer, if this is acceptable to recipients), grant funds may be used to procure a product that is recommended by the Expert Review Panel (ERP) of the Global Fund Secretariat.
ERP recommendations are valid only for 12 months, and these products are included in the Global Fund List of ARVs, anti-TB products and antimalarials.
ERP recommendations for finished pharmaceutical products (FPPs) must be in effect when a Principal Recipient (PR) or Sub-recipient (SR) signs the purchasing contract, and purchase orders under these contracts may be placed for a maximum term of 12 months. An FPP is defined as a medicine presented in its finished dosage form that has undergone all stages of production and is packed in its final container and labelled.
Before the PR completes a purchasing contract for a product that falls within neither Category A nor B, COs are required to inform the Global Fund if they intend to procure ERP-recommended pharmaceutical products. This is done by submitting the Notification Form to their Fund Portfolio Manager (FPM) with a copy to the Global Fund Senior Quality Assurance Technical Officer. The Global Fund Secretariat will review the notification request and will issue a ‘no objection’ letter to the PR if it is accepted. Only at this stage can the CO proceed with the procurement.
When placing an order for an ERP-recommended product, and before shipment of the product, the CO must notify the Global Fund. This will enable the Global Fund to contract a third-party laboratory to conduct random pre-shipment quality-control testing. The Global Fund is responsible for paying for these services. The products cannot be shipped until the PR is notified by the Global Fund that the quality-control test results were acceptable.
The Global Fund does enforce the QA policy with corrective measures when non-compliance is proven. A PR is considered non-compliant if he or she does not notify the Global Fund of his/her intent to procure health products that do not fall under Category A or B drugs or notify the Global Fund of the need for quality testing of such products. The corrective measures depend on the severity of the non-compliance.
Other finished pharmaceutical products (FPPs)
All FPPs, other than antiretrovirals, anti-tuberculosis and antimalarial FPPs, need only to comply with the relevant quality standards that are established by the National Drug Regulatory Authority (NDRA) in the country of use.