NAFDAC said blood and blood products are essential medicines that must be consistently available.
By Mmesoma Onwuka
365Daily – The National Agency for Food and Drug Administration and Control (NAFDAC) has strengthened its regulatory oversight of blood and blood products in Nigeria as part of efforts to improve transfusion safety and safeguard public health.
The agency said the initiative has the support of the Minister of Health and Social Welfare, Prof. Ali Pate, and is in line with global best practices and World Health Organisation (WHO) recommendations that blood and blood products be regulated by National Regulatory Authorities responsible for medicines.
NAFDAC said blood and blood products are essential medicines that must be consistently available while meeting required standards of quality, safety and affordability.
The agency said the enhanced regulatory framework would cover the entire blood transfusion chain, including donor assessment, collection, testing, processing, storage, transportation and eventual use.
“Blood and blood products are essential medicines and must be consistently available while meeting the required standards of quality, safety and affordability,” NAFDAC said.
It noted that countries including Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda already have regulatory systems for blood and blood products through their respective National Regulatory Authorities.
The agency said its readiness to take on the expanded responsibility was supported by its transformation into a modern, science-based regulatory authority.
NAFDAC has attained WHO Maturity Level 3, completed the WHO Global Benchmarking Maturity Level 3 reassessment, secured WHO prequalification for its drug laboratory and established internationally accredited laboratory and quality management systems.
According to the agency, “these capabilities provide a strong foundation for effective regulation of blood and blood products in Nigeria.”
As part of its preparedness, NAFDAC established the Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate to oversee the registration and regulation of relevant products.
The agency said 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 activities, including laboratory testing and lot release, while the Directorate of Evaluation and Research provides oversight of Good Manufacturing Practices.
NAFDAC also disclosed that an ultra-modern laboratory facility was being developed to further enhance its capacity to assess and conduct quality control of vaccines and other biological products.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, said the success of the regulatory initiative would depend on sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
“Effective regulation of blood and blood products requires sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders,” Adeyeye said.
She reaffirmed NAFDAC’s commitment to working with relevant authorities and stakeholders to establish a robust regulatory framework that would ensure the availability of safe, quality-assured and efficacious blood and blood products.
Adeyeye said the initiative would also help strengthen public confidence in Nigeria’s healthcare system.
“Our commitment is to establish a robust regulatory framework that ensures the availability of safe, quality-assured and efficacious blood and blood products while strengthening public confidence in Nigeria’s healthcare system,” she said.