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(Last Updated On: July 28, 2022)

WHO Certifies NAFDAC as ML3 Regulatory Authority


April 4, 2022,

WHO officially announced Nigeria’s National Regulatory Agencies (NAFDAC and PCN) as a Stable, well-functioning and integrated regulatory system maturity level 3 rating scale of the Global Benchmarking Tool (GBT).

The ML3 rating is the target of the World Health Assembly (WHA) Resolution 67.20 for Regulatory System Strengthening to improve capacity of the NRA to regulate medical products in an efficient, effective, and in a transparent manner as buttressed in the Sustainable Development Goal (SDG 3 – Target 3.8) to achieve a universal health coverage and access to safe, effective, quality and affordable essential medicines and vaccines for all.

The ML3 rating means NAFDAC have been found to function well, stable and eligible for inclusion into the transitional WHO Listed Authorities (WLA) after additional evaluation of their performance, a list that will comprise the world’s regulators of reference – that is, regulatory authorities that should be globally recognized as meeting WHO and other international standards.

Tanzania, Ghana, Nigeria, and Egypt have been ranked ML3 as effective regulatory systems on the African continent. Fewer than 30% of the world’s regulatory authorities are considered fully functioning and operational.

Global Benchmarking Evaluation

The GBT is a tool designed to evaluate the overarching regulatory framework and the component regulatory functions (e.g. Clinical Trial Oversight, Marketing Authorization, Vigilance, Laboratory Testing,  Licensing Inspection, Marketing Surveillance and Control, Regulatory Inspection, and National Regulatory System ) through about 268 sub-indicators that may also be grouped and examined according to nine cross-cutting categories or themes, for example, quality and risk management system, Processes, Human Resources, etc.

The GBT also incorporates the concept of ‘maturity level’ or ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 (existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement).

Nigeria was benchmarked for eight (8) functions out of the nine(9) regulatory function. Lot Release is for vaccine producing nations. The ML3 rating for Nigeria is for medicines regulation (locally produced and imported) and imported vaccines. The current ML3 status makes us eligible to commence another benchmarking for Lot Release function for vaccines locally manufactured and be enlisted as WHO Listed Authority.

Benefit of GBT ML3

The declaration has positioned NAFDAC as a Medicine Regulatory Agency with stable, well functioning and integrated regulatory system with the following benefits

  1. Promotes of good regulatory practices in ensuring access, to safe, effective, quality and affordable essential medicines and vaccines,
  2. Facilitate reliance, collaboration, recognition and harmonization among other regulatory authorities.
  3. Build trust among National Regulatory Authorities, Manufacturer, Healthcare Service provider and the consumers and boost pharmaceutical trade.
  4. Improve and validate the quality NAFDAC work in ensuring timely access to quality-assured medicines and ensures eligibility for vaccine pre-qualification.
  5. Provide efficient and quality regulatory oversight that boost local manufacturing of medicinal products that meet international standards
  6. Promote faster authorization of products and safety monitoring after authorization
  7. Eligible for inclusion into transitional WHO Listed Authority, which comprises of world’s regulators of reference.

See also,

  1. The declaration letter from WHO Geneva
  2. The List of ML3 Regulatory Agencies
  3. Congratulatory Note from WAHO
  4. Congratulatory Note from AMRH
  5. MITV News on NAFDAC Maturity Level 3 Attainment

Director General

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