The National Agency for Food and Drug Administration and Control (NAFDAC) has begun strengthening regulatory oversight of blood and blood products in Nigeria to improve their quality, safety and availability.
The move, announced in a statement issued on Friday, followed the support of the Minister of Health and Social Welfare, Muhammad Pate, and is in line with the World Health Organisation’s (WHO) recommendation that national regulatory authorities oversee blood and blood products as medicines.
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NAFDAC said blood and blood products are classified as essential medicines and should be consistently available, with their quality, safety and affordability assured.
The agency said stronger regulation would cover the entire blood transfusion chain, from donor assessment and blood collection to testing, processing, storage, transportation and eventual use.
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Why the regulation matters
Blood transfusion is an essential component of healthcare, particularly in emergencies, surgery, childbirth and the treatment of conditions requiring blood replacement.
NAFDAC said effective regulatory oversight would help ensure that blood and blood products meet required safety and quality standards at different stages before they reach patients.
It noted that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, have already placed blood and blood products under the oversight of their national regulatory authorities.
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The agency said Nigeria’s move was therefore intended to bring its regulatory system closer to global practices.
Regulatory capacity
NAFDAC said its decision was supported by recent improvements in its regulatory and laboratory capacity.
The agency said it has attained WHO Maturity Level 3 and successfully completed a WHO Global Benchmarking Maturity Level 3 reassessment.
It also said its drug laboratory has obtained WHO prequalification, while its laboratory and quality management systems have received international accreditation.
“These capabilities provide a strong foundation for the effective regulation of blood and blood products,” the agency said.
NAFDAC said it had also established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant products.
The agency said its Vaccines, Biologicals and Medical Devices Laboratory Services, which became a directorate in 2024, is responsible for quality control, including laboratory testing and lot release.
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The Directorate of Evaluation and Research, it added, provides oversight of Good Manufacturing Practices.
NAFDAC also said an ultra-modern laboratory facility is being developed to strengthen further its capacity to assess and conduct quality control of vaccines and biological products.
Agency seeks collaboration
The Director-General of NAFDAC, Mojisola Adeyeye, said effective regulation of blood and blood products would require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
Ms Adeyeye said the agency remained committed to establishing a regulatory framework to promote the availability of safe, quality-assured, and efficacious blood and blood products.
She said the framework would also help strengthen public confidence in Nigeria’s healthcare system.
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