WorldStage– The National Agency for Food and Drug Administration and Control (NAFDAC) is strengthening its regulatory framework for blood and blood products in Nigeria for public health safety.
According to a statement by the Director-General, Prof Mojisola Adeyeye, the move became necessary following the support it received recently from the Minister of Health and Social Welfare, Prof Muhammad Pate.
Adeyeye said that the move was also in line with global best practices and the World Health Organization (WHO) recommendation that these products be subjected to oversight by the National Regulatory Authorities (NRAs) for medicines.
According to her, blood and blood products are classified as essential medicines and must be consistently available with assured quality, safety and affordability.
She said that the move also represents an important step towards strengthening Nigeria’s health system and protecting patients throughout the blood 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.
“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.
“NAFDAC’s renewed regulatory preparedness builds on the agency’s broader transformation into a modern, science-based regulatory authority and the agency has attained WHO Maturity Level Three (ML3).”
Adeyeye added that NAFDAC has also 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,” the NAFDAC boss said.
She said that as part of NAFDAC preparedness, the agency has established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of the said products.
She said that though the agency had established a Vaccines, Biologicals and Medical Devices Laboratory Services many years ago, it became a Directorate in 2024, adding that it was responsible for quality control, including laboratory testing and lot release.
“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 biologicals.”
Adeyeye however said that effective regulation of blood and blood products requires sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
She said that NAFDAC 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.
