NAFDAC steps up oversight of blood products in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is boosting its regulation of blood and blood products in Nigeria. This effort aims to improve the quality, safety, and availability of these products.

This announcement came in a statement on Friday. It has the backing of the Minister of Health and Social Welfare, Muhammad Pate. The move aligns with the World Health Organisation’s (WHO) advice that national regulatory bodies should oversee blood and blood products as if they are medicines.

NAFDAC explained that blood and blood products are essential medicines. They should always be available, with quality, safety, and affordability guaranteed.

The agency stated that stronger regulations would cover the entire blood transfusion process. This includes donor assessment, blood collection, testing, processing, storage, transportation, and use.

Importance of Regulation

Blood transfusion is critical for healthcare. It is especially important in emergencies, surgeries, childbirth, and treating conditions needing blood replacement.

NAFDAC stressed that effective regulation would help ensure blood and blood products meet safety and quality standards at all stages before reaching patients.

It pointed out that several African countries have already placed blood and blood products under the oversight of their regulatory authorities. Countries like Egypt, Ghana, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda have taken this step.

The agency noted that Nigeria’s action aims to align its regulations with global practices.

Building Regulatory Capacity

NAFDAC said its decision is backed by recent improvements in its regulatory and laboratory capabilities.

The agency has reached WHO Maturity Level 3 and has completed a WHO Global Benchmarking Maturity Level 3 reassessment.

Additionally, its drug laboratory has received WHO prequalification. Its laboratory and quality management systems have also gained international accreditation.

"These capabilities provide a strong foundation for the effective regulation of blood and blood products," the agency stated.

NAFDAC has also set up a dedicated Vaccines, Biologicals, and Medical Devices Registration and Regulation Directorate. This body will manage the registration and regulation of relevant products.

The agency's Vaccines, Biologicals, and Medical Devices Laboratory Services became a directorate in 2024. It handles quality control, including laboratory testing and lot release.

Request for Collaboration

The Director-General of NAFDAC, Mojisola Adeyeye, said effective regulation of blood and blood products will need ongoing collaboration. This includes government institutions, healthcare providers, blood establishments, development partners, and other stakeholders.

Ms Adeyeye mentioned that the agency is committed to establishing a regulatory framework. This framework aims to promote the availability of safe, quality-assured, and effective blood and blood products.

She added that the framework would help build public confidence in Nigeria’s healthcare system.