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

Area of Science:

• Regulatory Science
• Public Health
• Blood Product Safety

Background:

• Independent assessments of blood regulatory systems are vital for improving access to safe blood, blood components, and products.
• The World Health Organization's Global Benchmarking Tool (GBT) plus Blood aids in developing National Regulatory Authorities (NRAs).

Purpose of the Study:

• To assess and compare the implementation and performance of regulatory functions for registration, marketing authorization, and approval of blood, blood components, and plasma for fractionation in African countries.
• To evaluate the effectiveness of regulatory systems using the GBT plus Blood tool.

Main Methods:

• Assisted self-benchmarking was conducted in 12 African countries using the GBT plus Blood tool.
• The study assessed 34 sub-indicators for the registration and marketing authorization function and 24 sub-indicators for the approval of blood, blood components, and plasma for fractionation function.
• Comparative assessments were made between World Health Organization-designated Maturity Level 3 (ML3) NRAs and non-designated NRAs.

Main Results:

• The registration and marketing authorization function showed higher implementation scores (average 73%) compared to the approval of blood, blood components, and plasma for fractionation function (average 45%).
• ML3-designated NRAs demonstrated significantly higher performance in registration and marketing authorization (91%) than non-designated NRAs (71%).
• Performance differences between ML3-designated and non-designated NRAs were minimal for the approval of blood, blood components, and plasma for fractionation function.

Conclusions:

• Most NRAs performed well in authorizing plasma-derived medicines but showed significant weaknesses in regulating blood, blood components, and plasma for fractionation processes.
• Regulatory frameworks for blood and blood products in the assessed African countries are largely nascent.
• Formal benchmarking of NRAs using the GBT plus Blood is urgently needed to strengthen regulatory capacities for blood and blood products in Africa.