The National Agency for Food and Drug Administration and Control (NAFDAC) has commenced enhanced regulatory oversight of blood and blood products in Nigeria, aiming to improve their quality, safety, and availability. This initiative, announced in a statement on Friday, follows the support of the Minister of Health and Social Welfare, Muhammad Pate, and aligns with the World Health Organisation’s (WHO) recommendation that national regulatory authorities supervise blood and blood products as medicines.
Scope of New Regulatory Oversight
NAFDAC stated that blood and blood products are classified as essential medicines and should be consistently available, with their quality, safety, and affordability assured. The strengthened regulation will cover the entire blood transfusion chain, from donor assessment and blood collection to testing, processing, storage, transportation, and eventual use.
Blood transfusion is a critical component of healthcare, particularly in emergencies, surgery, childbirth, and treatment of conditions requiring blood replacement. NAFDAC said effective regulatory oversight would help ensure that blood and blood products meet required safety and quality standards at different stages before reaching patients.
Alignment with Global Practices
Several African countries, including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda, have already placed blood and blood products under the oversight of their national regulatory authorities. NAFDAC noted that Nigeria’s move is intended to bring its regulatory system closer to global practices.
The agency said its decision is supported by recent improvements in its regulatory and laboratory capacity. NAFDAC has attained WHO Maturity Level 3 and successfully completed a WHO Global Benchmarking Maturity Level 3 reassessment. Its drug laboratory has obtained WHO prequalification, and its laboratory and quality management systems have received international accreditation.
Regulatory Capacity and Infrastructure
“These capabilities provide a strong foundation for the effective regulation of blood and blood products,” the agency said. NAFDAC has also established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant products.
The Vaccines, Biologicals and Medical Devices Laboratory Services, which became a directorate in 2024, is responsible for quality control, including laboratory testing and lot release. The Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices. Additionally, an ultra-modern laboratory facility is being developed to further strengthen NAFDAC’s capacity to assess and conduct quality control of vaccines and biological products.
Collaboration and Future Steps
The Director-General of NAFDAC, Mojisola Adeyeye, said effective regulation of blood and blood products would require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners, and other stakeholders. She reaffirmed the agency’s commitment to establishing a regulatory framework to promote the availability of safe, quality-assured, and efficacious blood and blood products, which would also help strengthen public confidence in Nigeria’s healthcare system.
