By George Ozalla
The National Agency for Food and Drug Administration and Control (NAFDAC) has strengthened its regulatory framework for blood and blood products in Nigeria, with the agency saying the move is aimed at ensuring their safety, quality, availability and affordability.
NAFDAC 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 should be subject to regulatory oversight by National Regulatory Authorities for medicines.
According to the agency, blood and blood products are classified as essential medicines and must be consistently available with assured quality and safety. It said effective regulation would protect patients at every stage of the blood transfusion process, from the point of donor assessment and collection to testing, processing, storage, transportation and eventual use.
NAFDAC described the development as an important step in strengthening Nigeria’s health system, noting that proper regulatory oversight would provide greater assurance that blood and blood products used in healthcare facilities meet required standards.
The agency also pointed to developments in other African countries, saying Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda have already established regulatory oversight of blood and blood products through their respective National Regulatory Authorities.
NAFDAC said its preparedness to take on the expanded responsibility was supported by reforms that have strengthened its regulatory and laboratory capacity in recent years. The agency has attained WHO Maturity Level 3 and successfully completed the WHO Global Benchmarking Maturity Level 3 reassessment.
It also obtained WHO prequalification for its drug laboratory and established internationally accredited laboratory and quality management systems. NAFDAC said these capabilities provide the foundation required for effective regulation of blood and blood products.
As part of the preparations, the agency established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant products.
NAFDAC explained that its Vaccines, Biologicals and Medical Devices Laboratory Services, which had existed for several years, was upgraded to a directorate in 2024. The directorate is responsible for quality control, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices.
The agency further disclosed that an ultra-modern laboratory facility is being developed to strengthen its capacity to assess and carry out quality control of vaccines and biological products.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, said the effective regulation of blood and blood products would require sustained cooperation among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
Adeyeye said NAFDAC was committed to working with relevant authorities and stakeholders to establish a strong regulatory framework that would promote the availability of safe, quality-assured and efficacious blood and blood products.
She added that the effort would also help strengthen public confidence in Nigeria’s healthcare system, particularly in the safety and reliability of blood and blood products used in medical treatment.
The agency said the strengthened framework would complement its broader regulatory reforms and provide greater oversight of products that are critical to patient care and the functioning of the health system.
