News Releases

Global Fund, PEPFAR and Unitaid Collaboration Paves Way to Accelerate Approval of African-Manufactured HIV Rapid Tests

08 August 2023

Geneva – The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund), the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and Unitaid are partnering to accelerate the manufacturing of health products in Africa, with HIV rapid diagnostic tests (RDTs) as the initial focused product category.

With support from the World Health Organization (WHO), the Global Fund, in partnership with PEPFAR and Unitaid, is launching a pilot, open Expert Review Panel for Diagnostic Products (ERPD) call for Expression of Interest (EOI) for African manufacturers of HIV RDTs to accelerate the availability of quality assured RDTs in Africa.

By issuing this call for EOI, the Global Fund is inviting manufacturers of HIV in-vitro diagnostic products conducting some, or all, of the manufacturing steps in Africa to submit their product information for review. Once a submission is accepted by the Global Fund, the ERPD – an independent panel of technical experts convened by WHO – will conduct an assessment of the potential risks linked to the procurement and use of such diagnostic products that have not yet been prequalified by WHO or authorized for use through a stringent regulatory review.

“Promoting capacity building for regional manufacturing is important, particularly in Africa, to contribute to building resilient health systems and driving equitable access to quality-assured products,” said Peter Sands, Executive Director of the Global Fund. “As a global health partnership, the Global Fund is poised to support this work, recognizing that it is owned and led by the continent.”

The ERPD makes recommendations to the Global Fund for procurement. The outcome of the ERPD assessment will be shared with partners to enable wider distribution of the assessed products. Products considered by the ERPD to have an acceptable risk-benefit profile for procurement will need to continue working towards compliance with quality standards through prequalification or another stringent regulatory review with lifecycle regulatory oversight. More details on the ERPD, which is hosted by the WHO Regulation and Prequalification department, are available here.

“WHO welcomes this important initiative, which addresses two key priorities: the need for a reliable supply of rapid HIV test kits so that everyone with HIV in Africa can access lifesaving treatment; and the need for enhanced local manufacturing of medical products in Africa, to build capacities and reduce reliance on imports," said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO.

This is a pivotal milestone in the organizations’ joint efforts to accelerate the supply diversification agenda, which contributes to more equitable access to quality-assured health products, more resilient supply chains and supply security. Manufacturers and partners are invited to join an information session on the Call for EOI on 10 August at 14:00 Central European Summer Time (CEST).

Today, many health products – including HIV tests – are manufactured far from where they are used, compromising their equitable and timely supply. This reality became glaringly apparent during the COVID-19 pandemic, when global supply chain disruption had a disproportionate impact on regions that were net importers of health products.

"Strengthening regional manufacturing of quality-assured diagnostics and other critical health commodities on the African continent is a key priority for PEPFAR,” said Ambassador Dr. John Nkengasong, U.S. Global AIDS Coordinator and Senior Bureau Official for Global Health Security and Diplomacy at the U.S. Department of State. “Supporting African-based manufacturing of HIV rapid tests will build a strong foundation for longer term capacity of diagnostic manufacturing for all health threats, and will ensure supply security, patient access, and contribute to global health security.”

"Unitaid is firmly committed to strengthening manufacturing capacity of health products in Africa,” said Philippe Duneton, Executive Director of Unitaid. “We join hands with global health partners to take this critical step towards greater access to health products, including diagnostics. Investing in and supporting a robust regulatory framework, alongside technical, procurement and demand generation support to manufacturers, will help ensure the quality and safety of these tests, expedite their deployment and expand access for all.”

The Global Fund continues to drive equitable access to quality-assured health products. Through its NextGen market-shaping approach, the Global Fund is working closely with partners to implement interventions that accelerate new product introduction, support capacity building for regional manufacturing and procurement, and promote sustainable supply chains and country capacity strengthening at global, national and community levels.