This Stakeholders’ Report provides a comprehensive analysis of key regulatory developments and legislative changes affecting Nigeria’s health and pharmaceutical sector during the year 2025 (the Report Period). The report focuses on regulatory advancements that impact pharmaceutical manufacturers, distributors, healthcare providers, investors, and other stakeholders within the sector.

The year 2025 marked a transformative period characterized by unprecedented regulatory advancement, strategic infrastructure investments, and a renewed commitment to aligning domestic healthcare standards with international best practices. Nigeria’s achievement as the first African nation to sustain the World Health Organisation’s (WHO) Maturity Level 3 (ML3) status stands as a testament to years of systematic regulatory strengthening and institutional capacity building. This milestone, coupled with the gazetting of comprehensive pharmaceutical traceability regulations and the operationalization of specialized cancer treatment facilities, signals a maturing ecosystem where quality assurance, patient safety, and therapeutic access converge as policy priorities.

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