The journey and vision of the African blood regulators technical committee (ABR-TC)

Despite these advances, regulatory systems for blood and blood products in Africa have not kept pace. Nine countries have achieved maturity level 3 (ML-3) using the WHO Global Benchmarking Tool (GBT), but no African country has yet reached ML-3 under the GBT+Blood framework. This highlights persistent weaknesses in regulatory oversight across the continent, posing risks to the safety, quality, and effectiveness of blood products used in clinical care. Regulatory gaps also contribute to the widespread wastage of surplus plasma used as raw material in the manufacturing of Plasma Derived Medicinal Products (PDMPs).

In the absence of clear legal, regulatory, and quality frameworks for plasma qualification and approval for fractionation, potentially valuable plasma is often discarded. This occurs despite substantial unmet needs for PDMPs, including coagulation factors for haemophilia, immunoglobulins for immunodeficiency disorders, albumin for critical care, trauma, burns, and liver disease, and anti-D immunoglobulin to prevent haemolytic disease of the newborn. Collectively, these challenges represent a missed opportunity to improve patient outcomes and a structural barrier to self-sufficiency, sustainability, and resilience in Africa’s blood and plasma systems.

To address this gap, WHO-convened regional discussions between national regulatory authorities (NRAs) and national blood transfusion services led to the establishment of the African Blood Regulatory Forum (ABRF) in March 2018. Despite disruptions caused by the COVID-19 pandemic, the ABRF developed key guidance documents, including recommendations for the use of convalescent plasma as treatment of COVID-19 and Good Manufacturing Practice (GMP) guidelines for Blood Establishments (Bes). In May 2025, the Forum was reconstituted as the African Blood Regulatory Technical Committee (ABR-TC).

The ABR-TC brings together regulators and blood transfusion experts from across Africa, including representatives from Regional Economic Communities (RECs), alongside observers from WHO, the Paul-Ehrlich-Institute (PEI), ISBT, Swissmedic, and experts from the plasma industry. Its work is organised through five sub-committees: Operationalization, Advocacy, Resource Mobilization, Capacity Building, and Technology Transfer. AUDA-NEPAD and WHO jointly host the Secretariat, supporting coordination and advancing regulatory harmonisation and cooperation across the continent.