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From Adesuwa Tsan, Abuja
The Senate has began consideration of a bill that would, for the first time, bring emerging medical and health technologies such as in vitro diagnostic devices, artificial intelligence-assisted diagnostics, biotechnology and genetically modified products under a comprehensive legal and regulatory framework.
It seeks to repeal the Food, Drug and Related Products (Registration, Etc.) Act and the Food and Drug Act, replacing them with a single law to regulate food, medical products and other health-related products in line with global best practices.
Leading debate on the bill’s general principles in plenary on Tuesday, Suleiman Sadiq said Nigeria’s existing regulatory laws were enacted decades ago when pharmaceutical manufacturing, food production and healthcare technologies were far less advanced.
He argued that rapid developments in biotechnology, in vitro diagnostic technologies, artificial intelligence-assisted diagnostics, online pharmaceutical commerce and increasingly complex global supply chains have outpaced the country’s current legal framework.
“The regulatory landscape has changed dramatically,” he said, noting that the world now deals with biotechnology, advanced medical devices, in vitro diagnostic technologies, artificial intelligence-assisted diagnostics, online pharmaceutical commerce and sophisticated criminal networks engaged in the production and distribution of harmful products.
According to him, the proposed legislation establishes a comprehensive statutory regime for all products regulated by the National Agency for Food and Drug Administration and Control (NAFDAC), harmonising existing laws while eliminating obsolete provisions.
The bill expands the scope of regulated products beyond food, drugs, cosmetics and conventional medical devices to include processed animal feeds, active pharmaceutical ingredients, medical devices, in vitro diagnostic devices, vaccines, tobacco products, chemicals, packaged water, home care products and other products capable of affecting public health.
Sadiq said the legislation introduces statutory provisions governing product evaluation before registration, post-marketing surveillance, continuous safety monitoring throughout a product’s lifecycle, supply chain traceability and mandatory product recalls where public health is threatened.
A major innovation in the bill, according to the sponsor, is the introduction of a comprehensive legal framework for clinical trials, performance evaluations and human intervention studies, areas not comprehensively covered under existing laws.
The bill also seeks to institutionalise internationally recognised standards, including Good Manufacturing Practices, Good Distribution Practices, Good Storage Practices, Good Clinical Practices and Good Laboratory Practices to improve product quality and safety.
In addition, it strengthens NAFDAC’s statutory powers for inspection, investigation, sampling, detention, seizure and enforcement, while preserving due process and accountability.
Sadiq said the reforms would position Nigeria to align its regulatory framework with international standards, enhance cooperation with foreign regulators and improve the competitiveness of Nigerian products in regional and global markets.
He maintained that the legislation would not only modernise regulation of rapidly evolving health technologies but also strengthen consumer protection, support local manufacturing and improve public health outcomes.
The bill was subsequently read a second time and referred to the Senate committee on Health (primary and tertiary) for further legislative consideration.
