Quality Assurance Policy for Pharmaceutical Products

For any pharmaceutical products to be eligible for purchase with the Global Fund resources, its compliance with quality standards must be assured.

Marketing authorization in country of use

All finished pharmaceutical products (FPPs), must comply with the relevant quality standards established by the National Drug Regulatory Authority (NDRA) in the country of use

Criteria for ARVs, anti-TB products and antimalarials:

In addition to approval by the NDRA in the country of use, all ARV, Anti-TB and Anti-Malaria pharmaceutical products should meet the following as per the revised QA Policy

1. ‘A’ Product - products are prequalified by the WHO Prequalification Programme; 
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   OR

2. ‘B’ Product - products are approved or authorized for use by a stringent regulatory authority (a member, observer or associate of ICH);
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ERP-reviewed products

If only one or no A or B product is available on the global market, grant funds may be used to procure a product which is reviewed by the Expert Review Panel (ERP) and permitted for time-limited use.

The Global Fund periodically publishes Invitations for Expression of Interest by manufacturers on the Information to Suppliers page. Interested manufacturers submit a questionnaire and attached technical documentation.

Lists of A, B and ERP-reviewed products

Tool for procurement, updated monthly based on the following information:

• WHO Prequalification Programme publishes the list of prequalified (“A”) products.  
• For “B”  products, manufacturers are invited to submit the following documentation:

1. Copy of approval or registration certificate or marketing authorization from a stringent regulatory authority (SRA);

2. Copy of GMP (Good Manufacturing Practice) certificate issued by an SRA, a PIC member or the WHO Prequalification Programme certifying the compliance of the manufacturing site with WHO GMP requirements

The Global Fund updates the section on ERP-reviewed products after each ERP review.

Principal Recipients should still obtain evidence of product status.

Before procuring ERP-reviewed products

Before procuring ERP-reviewed products, Principal Recipients (PRs) must inform the concerned Fund Portfolio Manager (FPM) at the Global Fund in writing by filling in the “Notification Form”.
Procurement can only proceed once the PR receives a “no objection” letter from the Global Fund Secretariat for the requested selection.

Pre-shipment QC testing and results 

The Global Fund is only responsible for QC of ERP-reviewed products for which a notification has been received (see above). Testing is performed by an independent laboratory contracted by the Global Fund. Upon successful QC results, the Secretariat will approve product shipment by issuing a final letter, including the test report, to the PR and concerned manufacturer.

Monitoring product quality 

Monitoring Product Quality (for all pharmaceutical products (including A, B, ERP-reviewed and other products): PR is responsible for random quality control of all finished pharmaceutical products (including A or B classified products) procured with Global Fund resources along the whole supply management chain system.