Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 May 1:12:1519719.
doi: 10.3389/fmed.2025.1519719. eCollection 2025.

Bridging the gap: enhancing blood regulatory functions in African contexts through comparative analysis

Washington T Samukange  1   2   3 , Verena Kluempers  1 , Chancelar Kafere  1 , Kristina Heinrich  1 , Joanna Atemnkeng  1 , Alireza Khadem Broojerdi  4 , Florence Tirane  5 , Edwin Nkansah  6 , Shani Maboko  7 , Linda Nhukarume  8 , Khamusi Mutoti  9 , Noel Aineplan  10 , Helga Gardasdottir  2   11   12 , Aukje K Mantel-Teeuwisse  2 , Jens Reinhardt  13
Affiliations

Bridging the gap: enhancing blood regulatory functions in African contexts through comparative analysis

Washington T Samukange et al. Front Med (Lausanne). .

Abstract

Introduction: Independent assessments of blood regulatory systems, facilitated by tools such as the WHO's Global Benchmarking Tool (GBT) plus Blood expedites development of National Regulatory Authorites (NRAs) and thus promotes increased access to safe, effective, and quality blood, blood components, and products. The aim of this study was to assess and compare the status of implementation and performance of the regulatory functions for registration and marketing authorization as well as the system for approval of blood, blood components and plasma for fractionation or processes.

Methods: We did this by conducting assisted self-benchmarking in 12 African countries using the GBT plus Blood (registration and marketing authorization function, 34 sub-indicators and approval of blood, blood components, and plasma for fractionation or processes function, 24 sub-indicators). Comparative assessments of WHO-designated maturity level 3 (ML3) NRAs for medicines and vaccines against non-designated NRAs were made.

Results: The percentage of implemented sub-indicators was higher for the registration and marketing authorization function with an average implementation score of 73% (range: 51%-92%) compared to the approval of blood, blood components, and plasma for fractionation or processes function which had an average implementation score of 45% (range: 6%-65%). The comparison of group averages for the ML3-designated NRAs against the non-designated NRAs revealed a higher score 91% (range: 71%-100%) for ML3-designated NRAs as opposed to a lower score of 71% (range: 49%-100%) for the non-designated NRAs for the registration and marketing authorization function. This pattern, however, was not observed for the comparison of group averages for the approval of blood, blood components, and plasma for fractionation or processes function where the ML3-designated NRAs scored 47% (range 19%-72%) against 46% (range 23%-88%) for the non-ML3-designated NRAs.

Conclusion: Most of the NRAs excelled in implementing sub-indicators for the registration and marketing authorization (of plasma-derived medicines) function. All NRAs exhibited notable flaws in regulating blood, blood components, plasma for fraction, and approval of processes, indicating nascent regulatory frameworks. This study highlights the urgent need for WHO and African countries to prioritize formal benchmarking of NRAs using the GBT plus Blood to enhance their regulatory capacities in blood and blood product regulation.

Keywords: GHPP BloodTrain; Sub-Saharan African countries; availability of safe blood; blood and blood products; global benchmarking tool.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Overall implementation of registration and marketing authorisation of plasma-derived medicines and approval of blood and blood components including plasma for fractionation or processes functions in benchmarked country NRAs.
Figure 2
Figure 2
(A) Overall performance of registration and marketing authorization of plasma-derived medicines function in benchmarked country NRAs. (B) Overall performance of approval of blood and blood components including plasma for fractionation or processes function in benchmarked country NRAs
Figure 3
Figure 3
(A) Comparison of performance of indicators for ML3 NRAs vs non ML3 countries for the registration and marketing authorization function (plasma — derived medicines). (B) Comparison of performance of indicators for ML3 NRAs vs non ML3 countries for the approval of blood and blood components including plasma for fractionation function.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Klein HG, Hrouda JC, Epstein JS. Crisis in the sustainability of the U.S. blood system. N Engl J Med. (2017) 377:1485–88. 10.1056/NEJMsb1706496 - DOI - PubMed
    1. Epstein J, Seitz R, Dhingra N, Ganz PR, Gharehbaghian A, Spindel R, et al. . Role of regulatory agencies. Biologicals. (2009) 37:94–102. Available online at: https://www.sciencedirect.com/science/article/abs/pii/S1045105609000050?... - PubMed
    1. Epstein JS. Best practices in regulation of blood and blood products. Biologicals. 40:200–4. 10.1016/j.biologicals.2011.11.002 - DOI - PubMed
    1. Weimer A, Tagny CT, Tapko JB, Gouws C, Tobian AAR, Ness PM, et al. . Blood transfusion safety in sub-Saharan Africa: a literature review of changes and challenges in the 21st century. Transfusion. (2019) 59:412–27. 10.1111/trf.14949 - DOI - PubMed
    1. Barro L, Drew VJ, Poda GG, Tagny CT, El-Ekiaby M, Owusu-Ofori S, et al. . Blood transfusion in sub-Saharan Africa: understanding the missing gap and responding to present and future challenges. Vox Sang. (2018) 113:726–36. 10.1111/vox.12705 - DOI - PubMed

LinkOut - more resources