NAFDAC unveils roadmap to enhance standards, regulatory inspections

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced new roadmaps to institutionalise best practices and strengthen regulatory inspections in the country.

The agency’s Director General, Prof Mojisola Adeyeye, who spoke on the initiative, said the agency’s strategic focus will be on institutionalising best practices and strengthening regulatory inspections to achieve World Health Organisation (WHO) Listed Authority Status (WLA) and attain Maturity Level four (ML4) certification.

Adeyeye explained that the roadmap includes adopting and implementing international standards such as the International Council for Harmonisation known as ICH E6 (R3) and ICH M13. Additionally, NAFDAC is targeting the Pharmaceutical Inspection Cooperation Scheme (PIC/S) certification to enhance its regulatory inspection capabilities.

She emphasised the continued reliance on the Codex Alimentarius standards to ensure food products’ quality, safety, and marketability. In 2024, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) received a three-year grant from the Bill & Melinda Gates.

The funding was to provide necessary resources to strengthen regulatory inspection standards and facilitate improved access to quality medicines in African countries. According to the Pharmaceutical Convention, the project is expected to prepare several African National Regulatory Authorities for entry into PIC/S.

The agency also plans to reduce postpartum haemorrhage, maternal deaths, and child morbidity by ensuring the availability of high-quality health products such as oxytocin, tranexamic acid, and carbetocin.

According to the DG, this stance aligns with the declaration of 2025 as the “Maternal, Newborn, and Child Health & Nutrition Year.” The Food Safety and Applied Nutrition Directorate will also bolster its efforts by providing training in ISO 22,000 and HACCP protocols, to improve officer competence. The agency will expand its Breast Milk Substitute (BMS) Code monitoring across more states.

She stated that the agency would incentivise manufacturers to develop pediatric medicines, conduct surveys to monitor medicine quality and support the regulation of Ready-to-Use Therapeutic Foods (RUTF) for malnourished children. The new soybean-based RUTF will undergo stringent inspection and testing to ensure quality.

NAFDAC also plans to amplify herbal medicines by collaborating with the Nigerian Natural Medicine Development Agency (NNMDA). The agency will pursue clinical trials for listed herbal products and focus on developing a Nigerian Herbal Pharmacopoeia and a digital database of traditional medicines.

Categories under consideration include treatments for malaria, hypertension, diabetes, arthritis, and immune-boosting formulations.

The agency will revamp cosmetics regulation by introducing more localised manufacturing support and carrying out a comprehensive study comparing locally made and imported products. Training sessions for stakeholders will also be conducted quarterly to enhance understanding of the impact of cosmetics on health.

Adeyeye revealed that NAFDAC has ceased the registration of sachet alcohol products as part of its efforts to curb substance abuse and its associated health risks. Additionally, the agency is stepping up sensitisation campaigns about the dangers of unsafe food products, particularly those prepared under unhygienic conditions or sold without proper storage.

Despite the challenges posed by inadequate infrastructure, she expressed the agency’s commitment to improving public health outcomes through robust regulatory measures and stakeholder engagement.