Regional
The journey and vision of the African blood regulators technical committee (ABR-TC)
Moses Akampurira
School of Health Sciences, Makerere University, Kampala, Uganda
Alex Mutai
Blood Products at the Pharmacy and Poisons Board, Kenya
Florence Tirane
Zambia Medicines Regulatory Authority (ZAMRA), Lusaka, Zambia
Fonkou Steve
Cameroon Baptist Convention Health Services (CBCHS), Cameroon
Over the past decades, blood transfusion practices across Africa have improved significantly, enhancing the quality, safety, and availability of blood and blood components. Many Member States have also advanced access to plasma-derived medicinal products (PDMPs) through various mechanisms. These gains have been driven in part by key World Health Assembly (WHA) decisions, notably resolution WHA63.12 (2010), which urged countries to establish nationally coordinated and sustainable blood and plasma programmes based on voluntary, non-remunerated donation, while strengthening regulation, quality systems, and local plasma fractionation capacity.
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.
ABR TC Meeting in Kenya, May 2025
ABR TC Meeting in Kingali, December 2025
Work of the ABR-TC since reconstitution in May 2025
In May 2025, when the ABRF convened in Nairobi, Kenya, it was reconstituted and its operations formalized under the governance framework of the African Medicines Regulatory Harmonisation Program (AMRH). During this meeting, the TC elected Moses Akampurira as -Chairperson, Florence Tirane as-Vice Chairperson and Alex Mutai as -Rapporteur.
The Committee has since embarked on the development and adoption of key documents including:
- Adopted the revised Terms of Reference (ToRs) to guide its operations.
- The Good Practice Guideline for BEs (aligned with WHO Technical Report Series No. 1060 Annex 4, 2025)
- The AU Model Regulations for Control of Blood and Blood Products, developed by the Medicines Policy and Regulatory Reforms Technical Committee (MPRR-TC) were also discussed and adopted by the ABR-TC
- The Guidelines on a Stepwise Approach for Establishing Nationally Regulated Blood Systems were discussed and are progressing towards completion.
- A workplan of activities and a budget for the TC to be executed in the calendar year 2026, discussed and adopted in Kigali, Rwanda in December 2025.
Looking to the future state of blood regulation in Africa The WHO African Region Framework (2026–2030) envisages that by 2030 at least 20% of African countries (10 out of 47) will have established functional national blood regulatory systems, thereby laying the foundation for progressive advancement towards WHO GBT maturity level 3 for blood products oversight across the continent. In this context, the groundwork undertaken by the African Blood Regulators Technical Committee (ABR-TC) represents a critical enabling precursor to achieving this milestone. The guidelines and model regulations approved by ABR-TC, once they have completed the requisite approval pathways, will be published and made available to Member States. Countries are strongly encouraged to adopt and adapt these instruments as practical tools to accelerate the development of national blood regulatory systems. Their use is expected to generate important dividends in regulatory harmonisation, as Member States will be anchoring their legal and regulatory frameworks on a common, consensus-based blueprint. Looking ahead, the African Medicines Agency (AMA) will play a pivotal role in supporting and sustaining progress in the regulation of blood products. Ensuring that blood products are accorded dedicated and visible attention within AMA’s technical architecture, including through a recognised Technical Committee, will be important to consolidate gains and to safeguard the effective regulation under the distinct and specialised regulatory domains associated with blood products. These include, among others, the licensing of BEs, and the approval of blood, blood components, and plasma for fractionation, which require tailored regulatory approaches that may not be fully addressed in the absence of a focused technical mechanism. Despite challenges faced with regard to regulatory capacity on the continent, the ABR-TC has made progress in ensuring that the standards for regulation of blood products are harmonized and are consistent with internationally recognized best practices to safeguard the transfusion chain. Country-driven implementation, and regional solidarity offer a sustainable pathway to achieving regulatory harmonization and convergence across Africa. The ABR-TC calls on the continuous collaboration, investment and support of government, scientific community and international collaborators in their work of strengthening blood products regulatory systems.
