COVID-19

Quality assurance

The Global Fund maintains flexibilities to ensure the continued flow of quality-assured health products and support countries in their response to COVID-19.

Our operational guidance for Principal Recipients relates to requirements for procuring eligible COVID-19 diagnostic products and managing exceptions on quality assurance testing and sampling. Additionally, we regularly update our list of COVID-19 diagnostic products eligible for procurement with Global Fund financing, in line with our Interim Quality Assurance Requirements.

  • Interim Quality Assurance Requirements for the Procurement of COVID-19 Diagnostic Products
    download in English
  • List of SARS-CoV-2 Diagnostic Test Kits and Equipment Eligible for Procurement: COVID-19
    download in English
  • Management of Limited Exceptions to Quality Assurance Policy Requirements for Pre-Shipment Inspection and Testing
    download in English

As presented in the COVID-19 Response Mechanism Technical Information Note, the table below provides an overview of Quality Assurance Requirements for COVID-19 Health Products.

Pharmaceutical products[1] Diagnostic products Core Personal Protective Equipment Medical Devices (exclusive of PPE and condoms) [2]

Clinical requirements

Current national, institutional and/or WHO Standard Treatment Guidelines and/or Essential Medicines Lists

National guidelines and/or conformity with WHO guidance

National policy/guidelines on infection prevention and control and/or conformity with WHO guidance

National policy/guidelines on infection prevention and control and/or conformity with WHO guidance

Quality requirement

(1) Approved by national regulators; and

(1) Approved by national regulators;

(2) Is manufactured at a site that complies with relevant quality management system requirements; and

(1) Approved by national regulators; and

(1) Approved by national regulators; and

(2) Approved under the WHO Emergency Use and Listing procedures or under other emergency procedures set up by any Stringent Regulatory Authority as defined under the Global Fund QA Policy for Pharmaceuticals)

(3) Approved under the WHO Emergency Use and Listing procedures or under other emergency procedures set up by any Stringent Regulatory Authority as defined under the Global Fund QA Policy for Diagnostics)

(2) Approved by Stringent Regulatory Authorities (Founding Members of the Global Harmonization Task), WHO Prequalification Programme or Expert Review Panel

(2) Approved by Stringent Regulatory Authorities (Founding Members of the Global Harmonization Task), WHO Prequalification Programme or Expert Review Panel

[1] - This category is exclusive of essential medicines used for the management of patients with suspected or confirmed COVID-19 diagnosis. Quality assurance requirements for essential medicines are specified in Global Fund’s Quality Assurance Policy for Pharmaceutical Products.

[2] - This is a preliminary statement which will be confirmed through the next update to the Guide to Global Fund Policies on Procurement and Supply Management of Health Products.

Information related to the quality assurance of health products related to the three diseases is on our Quality Assurance pages.