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Vaccines

Nigeria's NAFDAC Retains WHO's Maturity Level 3 Status for Regulating Medicines and Vaccines

Strategic Insights

— 2 min read

President Bola Tinubu has congratulated the National Agency for Food and Drug Administration and Control (NAFDAC) on retaining the World Health Organisation's (WHO) Maturity Level 3 (ML3) status for the regulation of medicines and vaccines. This achievement is a result of NAFDAC's successful maintenance of a regulatory system that operates as a stable, well-functioning, and integrated framework for regulating medicines and vaccines. The WHO's re-benchmarking exercise conducted from May 28 to May 30, 2025, assessed NAFDAC against globally recognised standards for regulatory performance. This evaluation followed a formal re-benchmarking in November 2024 and five Institutional Development Plan (IDP) review meetings between February and April 2025.

Key Takeaways:

  • NAFDAC retained WHO's Maturity Level 3 (ML3) status for regulating medicines and vaccines, becoming Africa's first National Regulatory Authority to achieve this milestone in 2022.
  • The WHO's re-benchmarking exercise was conducted from May 28 to May 30, 2025, assessing NAFDAC against globally recognised standards for regulatory performance.
  • The evaluation followed a formal re-benchmarking in November 2024 and five Institutional Development Plan (IDP) review meetings between February and April 2025.
  • President Tinubu welcomes the WHO's verdict, highlighting NAFDAC's professionalism, consistency, and dedication to safeguarding public health.
  • NAFDAC's management and staff were commended for their efforts in maintaining a regulatory system that operates as a stable, well-functioning, and integrated framework.
  • The President reaffirmed his administration's commitment to enhancing Nigeria's capacity to ensure the safety, quality, and efficacy of medicines and vaccines in line with international best practices.
  • He also upheld the progress made in upgrading over 17,000 primary health centres, improving maternal care and diagnostics in underserved communities, and training 120,000 frontline health workers.

Statistics:

  • NAFDAC achieved WHO's Maturity Level 3 status in 2022, becoming Africa's first National Regulatory Authority.
  • The WHO's re-benchmarking exercise was conducted from May 28 to May 30, 2025.
  • Five Institutional Development Plan (IDP) review meetings were held between February and April 2025.
  • Nigeria is working to upgrade over 17,000 primary health centres nationwide.
  • Maternal care and diagnostics are being improved in underserved communities.
  • 120,000 frontline health workers have been trained.
  • Nigeria aims to double national health insurance coverage within three years.

Sources:

  • WHO's re-benchmarking exercise (May 28 to May 30, 2025)
  • WHO's Maturity Level 3 (ML3) status for NAFDAC
  • NAFDAC's Institutional Development Plan (IDP) review meetings (February to April 2025)
  • President Bola Tinubu's congratulatory message
  • Nigeria's Renewed Hope Agenda for transforming the healthcare system

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