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NAFDAC, Other Agencies Launch Joint Drug Approval System In Africa


In a meeting which brought together the eight African drug regulatory agencies operating at World Health Organisation (WHO) Maturity Level 3 (ML3), the National regulatory authorities(NRA) launched a continentwide reliance mechanism aimed at accelerating access to quality-assured medicines, vaccines, and diagnostics while reducing duplication and regulatory costs.

Unveiled during a high level meeting hosted by the National Agency for Food and Drug Administration and Control (NAFDAC) in Abuja recently, the new mechanism establishes a collaborative framework among the ML3 agencies to harmonise regulatory processes, streamline approvals, and strengthen Africa’s pharmaceutical systems.

According to a joint statement from the agencies, the ML3 Reliance mechanism will enable faster product approvals across participating countries and help eliminate redundant procedures, leading to cost savings and more efficient oversight.

The initiative also seeks to establish a robust and reliable regulatory network that can serve as a model for other regions.

The mechanism is aligned with key African Union strategies, including the Pharmaceutical Manufacturing Plan for Africa, the African Medicines Agency (AMA), and Agenda 2063.

It also supports the African Pooled Procurement Mechanism (APPM) coordinated by the Africa CDC. Officials said the move represents a significant step toward enhancing Africa’s self-reliance in health product regulation and manufacturing, ultimately improving access and affordability across the continent.



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