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 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 options when selecting which antiretrovirals, tuberculosis medicines and malaria medicines to purchase. They can choose medicines that have been either:
The World Health Organization (WHO) 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 that participated until 2015 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, in June 2018 the Global Fund’s Policy Committee endorsed 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. This limits the definition of SRAs to those authorities that were ICH members or observers prior to 23 October 2015.
The WHO started a Listed Authority initiative (WLA) to provide a transparent and evidence-based pathway for more regulatory authorities to be globally recognized. This is intended to expand access to a regionally diverse supply of safe, efficacious, effective and quality health products. Newly listed authorities are expected at the beginning of 2024.
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.
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 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.