Bridging the gap: enhancing blood regulatory functions in African contexts through comparative analysis
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.
Authors
- Shani Maboko
- Florence Jonazi Tirane
- Alireza Khadem Broojerdi (ORCID: https://orcid.org/0000-0002-9177-6378)
- Khamusi Mutoti
- Noel Aineplan
- Aukje K. Mantel‐Teeuwisse (ORCID: https://orcid.org/0000-0002-8782-0698)
- Joanna Atemnkeng
- Kristina Heinrich (ORCID: https://orcid.org/0000-0001-9150-3217)
- Washington T. Samukange (ORCID: https://orcid.org/0000-0003-2455-879X)
- Verena Kluempers
- Chancelar Kafere
- Jens Reinhardt
- Edwin Nkansah
- Linda Nhukarume
- Helga Gardasdottir
Institutions
- World Health Organization - Pakistan (PK)
- University of Iceland (IS)
- Utrecht University (NL)
- Kampala Capital City Authority (UG)
- University Medical Center Utrecht (NL)
- World Health Organization (CH)
- Belgian Development Agency (BE)
- Ministry of Health, Community Development, Gender, Elderly and Children (TZ)
- Pharmo Institute (NL)
- Zimbabwe National Water Authority (ZW)
- World Health Organization - Zambia (ZM)
- Paul Ehrlich Institut (DE)
Publication Details
- Journal
- Frontiers in Medicine
- Published
- 2025-05-01
- DOI
- https://doi.org/10.3389/fmed.2025.1519719
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- World Health Organization
- auDA Foundation
- Bundesministerium für Gesundheit
- New Partnership for Africa's Development
- African Union