The National Agency for Food and Drug Administration and Control (NAFDAC) has moved to strengthen regulatory oversight of blood and blood products in Nigeria as part of efforts to protect patients and ensure the availability of safe, quality-assured and affordable blood.
The agency said the move represented a significant step towards strengthening Nigeria’s health system and protecting patients from risks associated with unsafe or substandard blood and blood products.
It said the initiative had received the support of the Minister of Health and Social Welfare, Prof Ali Pate, and was in line with global best practices and the recommendation of the World Health Organisation (WHO) that blood and blood products be regulated by National Regulatory Authorities (NRAs) for medicines.
NAFDAC, in a statement by its Director-General, Prof Mojisola Adeyeye, said blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability.
It said the regulation of blood and blood products was critical to ensuring that patients receive safe and effective transfusion services, while strengthening the overall quality and resilience of Nigeria’s healthcare system.
According to the agency, stronger regulatory oversight would cover the entire blood transfusion chain, including donor assessment, blood collection, testing, processing, storage, transportation and use.
NAFDAC noted that several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, had already established regulatory oversight of blood and blood products through their respective national regulatory authorities. “This renewed regulatory preparedness was part of our broader transformation into a modern, science-based regulatory authority.”
It noted that NAFDAC had attained WHO Maturity Level 3, successfully completed the WHO Global Benchmarking Maturity Level 3 reassessment and obtained WHO pre-qualification for its drug laboratory.
To this end, the agency said it had established internationally accredited laboratory and quality management systems, which it described as a strong foundation for the effective regulation of blood and blood products.
NAFDAC said it had established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant products.
It explained that its Vaccines, Biologicals and Medical Devices Laboratory Services, which was established several years ago, became a directorate in 2024 and responsible for quality control activities, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of good manufacturing practices.
NAFDAC also disclosed that an ultra-modern laboratory facility was being developed to further strengthen its capacity for the assessment and quality control of vaccines and biological products.
The agency said effective regulation of blood and blood products would require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
It assured that NAFDAC would continue to work with relevant authorities and stakeholders to establish a robust regulatory framework that would promote the availability of safe, quality-assured and efficacious blood and blood products. “The initiative would also help strengthen public confidence in Nigeria’s healthcare system,” it said.
