Implementers of programs for AIDS, tuberculosis or malaria that use Global Fund funds to purchase medicines must ensure those pharmaceutical products meet our quality standards.
Those standards are captured in our policy:
All finished pharmaceutical products procured with Global Fund funds must also at all times comply with the national regulations and relevant quality standards established by the national drug regulatory authority in the country of use, following its standard practices for registration or other forms of authorization.
In accordance with our quality assurance policy, implementing Principal Recipients have three options when selecting which antiretrovirals, antituberculosis medicines and antimalarial medicines to purchase. They can choose medicines that have been either:
The World Health Organization manages a program that prequalifies pharmaceutical and diagnostic products considered to be acceptable for procurement by the United Nations and specialized agencies. The international organization regularly publishes a list of prequalified products.
This refers to regulatory authorities participating in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Following a series of structural changes within ICH, the Global Fund’s Policy Committee endorsed in June 2018 the WHO Expert Committee on Specifications of Pharmaceutical Preparations’ interim definition of stringent regulatory authority (SRA) for purposes of interpretation of the Global Fund’s Quality Assurance Policy for Pharmaceutical Products, which would limit the definition of SRAs to those authorities that were ICH members or observers prior to 23 October 2015.
The Guide to Global Fund Policies on Procurement and Supply Management of Health Products will be updated to reflect this decision in its next version.
If only one or no product is available on the global market, a Principal Recipient may select a product that has been reviewed by the Global Fund’s Expert Review Panel and that is permitted for time-limited use.
Purchase of Expert Review Panel products: In cases where a Principal Recipient wishes to purchase products that have been reviewed by the Expert Review Panel, the Principal Recipient should obtain evidence of product status through the “no-objection letter” process. To do this, the Principal Recipient should complete a notification form, available below for download, and submit it to the Fund Portfolio Manager. The Global Fund will issue a no-objection letter for a time-limited period and the procurement can go ahead.
In cases where the Principal Recipient has ordered a product that has been reviewed by the Expert Panel Review and has notified the Fund Portfolio Manager, the Global Fund will conduct quality control testing. This testing is carried out by an independent laboratory contracted by the Global Fund. Once the product has been successfully tested, the Global Fund will approve shipment, notifying both the Principal Recipient and manufacturer.
The panel reviews products in two ways:
See our Expert Review Panel page for more information on the process and the panel.
We regularly publish and update lists of pharmaceutical products found compliant with our quality assurance policy to help Principal Recipients more easily identify the status of finished pharmaceutical products. They are available for download here.
In addition to the pre-shipment quality control testing mentioned above, Principal Recipients are responsible for conducting random quality control of all finished pharmaceutical products (including A or B classified products) procured with Global Fund resources along the entire supply chain.
As per quality assurance requirements, tests should be conducted by quality control laboratories that are prequalified or are ISO 17025 accredited. For ISO-accredited laboratories, the Global Fund also considers demonstrated experience in quality control testing on similar products. The World Health Organization manages a program that prequalifies laboratories for the quality control of pharmaceutical products, and it regularly publishes a list of these laboratories.
Guidance and tools are available for download to help in the monitoring of pharmaceutical product quality.