Implementers of programs for AIDS, TB or malaria who want to use Global Fund grants to purchase medicines must ensure that those pharmaceutical products meet the Global Fund’s quality standards as set out in the Quality Assurance Policy for Pharmaceutical Products.
All finished pharmaceutical products procured with Global Fund monies must 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.
When purchasing antiretrovirals (ARVs), anti-tuberculosis and antimalarial medications, there are three options. Implementers can choose medicines which have been either:
The WHO manages a program which prequalifies pharmaceutical and diagnostic products that are considered to be acceptable for procurement by the United Nations and specialized agencies. WHO regularly publishes the 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).
However, if only one or no product is available on the global market, countries may select a product that has been reviewed by the Expert Review Panel and which is permitted for time-limited use.
In cases where Principal Recipients wish to purchase products that have been reviewed by the Expert Review Panel, they should obtain evidence of product status through the “No-Objection Letter” process. They should complete the notification form and submit it to their 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 which has been reviewed by the Expert Panel Review and which has been notified to 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 the manufacturer.
In addition to the pre-shipment quality control testing mentioned above, Principal Recipients are responsible for conducting for random quality control of all finished pharmaceutical products (including A or B classified products) procured with Global Fund resources along the whole supply chain.
Tests should be conducted by quality control laboratories which are prequalified or which are ISO 17025 accredited. The Global Fund also considers experience in quality control testing part of these requirements.
WHO manages a program which prequalifies laboratories for the quality control of pharmaceutical products, and they regularly publish a list of these laboratories.
The following tools are available for Principal Recipients:
We regularly update and publish lists of pharmaceutical products classified according our Quality Assurance Policy.