By Precious Mark
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a major expansion of its regulatory framework to cover blood, blood components, and plasma-derived products across Nigeria.
The initiative, backed by the Minister of Health and Social Welfare, Prof. Ali Pate, aligns with global best practices and World Health Organization (WHO) benchmarks classifying blood and blood products as essential medicines that require strict oversight by National Regulatory Authorities.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, explained on Thursday, that establishing comprehensive regulatory controls is essential for protecting patients throughout every stage of the transfusion chain.
“Effective regulatory oversight will support the quality and safety of blood products from donor assessment and collection through testing, processing, storage, transportation and use,” Adeyeye noted.
The expanded oversight builds upon NAFDAC’s institutional transformation, which includes maintaining WHO Maturity Level 3 (ML3) status, receiving WHO prequalification for its pharmaceutical laboratories, and deploying internationally accredited quality management systems.
To operationalize the mandate, NAFDAC has created a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate.
The agency’s existing specialized laboratory services will manage batch releases and quality control testing, while its Evaluation and Research Directorate enforces Good Manufacturing Practice (GMP) compliance across blood establishments.
Adeyeye added that construction is currently underway on an ultra-modern laboratory facility designed to further enhance the agency’s technical evaluation capacities for biologicals, vaccines, and blood-derived therapies.
With this regulatory upgrade, Nigeria joins other African nations; including South Africa, Ghana, Egypt, Rwanda, Senegal, Tanzania, and Zimbabwe—that already regulate blood products under their national medicine regulatory authorities.
Adeyeye called for sustained cooperation among healthcare providers, blood banks, research institutions, and development partners to build a reliable national supply chain of safe, quality-assured blood products.