The National Agency for Food and Drug Administration and Control, NAFDAC, is stepping up regulatory oversight of blood and blood products in Nigeria in a move aimed at improving transfusion safety and protecting patients across the country.
The initiative, backed by the Minister of Health and Social Welfare, Professor Ali Pate, is being pursued in line with global best practices and recommendations of the World Health Organisation, WHO.
Under the proposed framework, blood and blood products will be regulated as essential medicines, with emphasis on ensuring their quality, safety, availability and affordability.
NAFDAC says stronger oversight will cover the entire blood transfusion chain from donor assessment and blood collection to testing, processing, storage, transportation and eventual use.
The Agency says the move is particularly important for strengthening Nigeria’s health system and reducing risks associated with unsafe or poor-quality blood products.
Several African countries, including Ghana, South Africa, Egypt, Tanzania, Zimbabwe, Senegal and Rwanda, have already placed blood and blood products under the regulatory oversight of their national medicines regulatory authorities.
NAFDAC says Nigeria is building on its recent progress as a science-based regulatory authority to ensure it is adequately prepared for the expanded responsibility.
The Agency has attained WHO Maturity Level Three, completed a WHO Global Benchmarking Maturity Level Three reassessment and secured WHO prequalification for its drug laboratory.
It has also established internationally accredited laboratory and quality management systems, which NAFDAC says provide a strong foundation for regulating blood and blood products.
As part of the preparations, the Agency established a dedicated Vaccines, Biologicals and Medical Devices Registration and Regulation Directorate in 2024 to oversee the registration and regulation of relevant products.
NAFDAC says its laboratory services are 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 to assess and control the quality of vaccines and other biological products.
NAFDAC Director-General, Professor Mojisola Adeyeye, says effective regulation of blood and blood products will require sustained collaboration among government institutions, healthcare providers, blood establishments, development partners and other stakeholders.
She says the Agency remains committed to establishing a robust regulatory framework that will promote access to safe, quality-assured and efficacious blood and blood products while strengthening public confidence in Nigeria’s healthcare system.
The initiative marks another step towards ensuring that patients who require blood transfusions can receive products that meet established standards of safety and quality.