*Prof. Mojisola Adeyeye, Director-General, National Agency for Food and Drug Administration and Control, emphasises the measure represents an important step in strengthening Nigeria’s health system, and protecting patients throughout the blood transfusion chain in the country
Isola Moses | ConsumerConnect
Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has emphasised the need to strengthen regulatory framework on blood and blood products in the West African country in line with global best practices.
NAFDAC noted the effort is in consonance with the World Health Organisation’s (WHO) recommendation that such products be subject to oversight by National Regulatory Authorities (NRAS) for medicines.
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Prof. Mojisola Adeyeye, Director-General of NAFDAC, disclosed this in a statement issued in Abuja, FCT.
Adeyeye observed that the measure represents an important step in strengthening Nigeria’s health system, and protecting patients throughout the blood transfusion chain.
The Director-General of NAFDAC explained that blood and blood products are classified as “essential medicines”, and must be consistently available with assured quality, safety and affordability.
She also said that effective regulatory oversight would support the quality and safety of blood products from donor assessment and collection through testing, processing, storage, transportation and use.
According to her, several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda, have already established regulatory oversight of blood and blood products by their NRAS.
Adeyeye as well noted that NAFDAC’s renewed regulatory preparedness builds on the agency’s broader transformation into a modern, science-based regulatory authority.
The statement further noted the NAFDAC Chief Executive disclosed the health regulatory agency had attained WHO Maturity Level 3, successfully completed WHO Global Benchmarking ML3 re-assessment, 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.
“As part of its preparedness, NAFDAC has established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of these products,” Adeyeye said.
She equally stated: “The Agency established a Vaccines, Biologicals and Medical Devices Laboratory Services many years ago but became a Directorate in 2024 that is responsible for quality control, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices.
“An ultra-modern laboratory facility is also being developed to further strengthen the Agency’s capacity for the assessment and quality control of vaccines and biologics”.
The Director-General stressed that effective regulation of blood and blood products requires sustained collaboration among government institutions, healthcare providers, blood establishments, development partners, and other stakeholders.
Adeyeye averred 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.