NAFDAC Strengthens Regulation Of Blood, Blood Products

The National Agency for Food and Drug Administration and Control (NAFDAC) has strengthened its regulatory framework for blood and blood products in Nigeria as part of efforts to safeguard public health and ensure the availability of safe and quality-assured blood for patients.

NAFDAC disclosed this in a statement issued on Thursday, August 13, 2026, saying the move followed support from the Minister of Health and Social Welfare, Prof Ali Pate, and aligns with global best practices and recommendations by the World Health Organisation (WHO).

According to the agency, blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability.

NAFDAC said the enhanced regulatory oversight would cover the entire blood transfusion chain, from donor assessment and collection through testing, processing, storage, transportation and use.

“The move represents an important step in strengthening Nigeria’s health system and protecting patients throughout the blood transfusion chain,” the agency said.

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It added that effective regulatory oversight would support the quality and safety of blood products at every stage of the process, noting that countries including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda have already established regulatory oversight of blood and blood products through their National Regulatory Authorities.

The agency said its renewed regulatory preparedness builds on its transformation into a modern, science-based regulatory authority.

NAFDAC said it has attained WHO Maturity Level 3, completed the WHO Global Benchmarking ML3 reassessment, obtained WHO prequalification for its drug laboratory and established internationally accredited laboratory and quality management systems.

“These capabilities provide a strong foundation for the effective regulation of blood and blood products,” the agency said.

As part of its preparedness, NAFDAC said it has established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of the products.

The agency said its Vaccines, Biologicals and Medical Devices Laboratory Services, which was established several years ago, became a directorate in 2024 and is responsible for quality control, including laboratory testing and lot release.

It added that the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices, while an ultra-modern laboratory facility is being developed to further strengthen its capacity to assess and control the quality of vaccines and biological products.

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, said effective regulation of blood and blood products requires sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.

Adeyeye said the agency remains committed to working with relevant authorities and stakeholders to establish “a robust regulatory framework that promotes the availability of safe, quality-assured and efficacious blood and blood products, while strengthening public confidence in Nigeria’s healthcare system.”

The agency said the strengthened regulatory framework is expected to contribute to safer blood transfusion practices and reinforce public confidence in the quality of blood and blood products available in Nigeria.