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WHO Global Benchmarking & Quality Management Program

Commencement of Agency Wide Quality Management System (QMS)

As one of its Strategic Objectives, the Top Management of NAFDAC has demonstrated its commitment to establishing and implementing QMS across all Regulatory and Agency operations to improve efficiency, transparency and accountability. This is demonstrated by the constitution of the Agency’s QMS Steering Committee and QMS responsible persons for all Directorates, Zones/States to coordinate QMS establishment and implementation in NAFDAC.

In a bid not only to attain ISO 9001:2015 Certification; but to imbibe quality culture in the Agency in all our processes; NAFDAC, through partial support from UNIDO/WAHO, started the implementation of QMS in April 2018 that included training of over 2,241 staff of the Agency for various levels of QMS (including but not limited to awareness, system development, internal auditing processes etc.).

Most QMS Documents like Quality Manual, Quality Policy, SOPs have also been developed, validated, approved and copies cascaded to the various Directorates and Zonal/State Offices and controlled copies of the Procedures distributed to facilitate implementation.

With the foregoing, QMS awareness is gradually building up in the Agency, as most staff of the Agency are embracing QMS principles.

To validate and verify implementation of some deployed procedures the QMS Steering Committee conducted a mock Audit in December 2018. Findings showed varied levels of QMS implementation across the Directorates. An all-day management meeting took place in April to harmonize the training and identify any gaps.   A follow-up of the management meeting took place at a retreat in early May 2019 where a comprehensive review of the QMS implementation in the Agency was carried out.  The retreat fostered closer interaction of the Directorates and the Agency’s QMS Steering Committee and closure of all identified gaps in preparation for the ISO 9001:2015 Certification Audit that will take place by end of May, 2019.

Commencement of Agency-Wide Global World Health Organization (WHO) Global Benchmarking Program

The WHO Benchmarking program is a method deployed by WHO to assess the maturity level of National Regulatory Authorities (NRA). The assessment is done using a computerized tool in the form of Microsoft Access database referred to as Global Benchmarking Tool (GBT).

The GBT consists of numerous indicators and sub – indicators which are used to evaluate nine (9) regulatory functions for drugs and vaccines. This computerized tool is used to generate automated report after being populated with responses and evidences. The generated report helps to identify gaps in regulatory functions and areas of improvement. The regulatory functions assessed with the GBT are:

  1. 1. National Regulatory System (RS)
  2. Registration and Marketing Authorization (MA)
  3. Licensing Establishments (LI)*
  4. Market Surveillance and Control (MC)
  5. Vigilance (VL)
  6. Regulatory Inspection (RI)
  7. Clinical Trials Oversight (CT)
  8. Laboratory Testing (LT)
  9. NRA Lot Release (LTR)*

* LI – A function of Pharmacists Council of Nigeria (PCN)

* LTR – A function applicable to countries with vaccine manufacturers

The WHO Benchmarking Program commenced in NAFDAC in January 2018 when a Benchmarking Team was constituted to assess the regulatory functions of the Agency using the WHO Global Benchmarking Tool (GBT). The team was able to conduct the first NAFDAC self-benchmarking assessment and the report was submitted to WHO and WAHO before the stipulated deadline.

The WHO Global Benchmarking Tool (GBT) has been used to determine the maturity level of Medicines Regulatory Authorities (MRA) globally. The maturity levels range from level 1-4 with the best level being 4, and WHO’s new term for MRAs that have attained level 4 is WHO Listed Regulatory Authorities (WLA).

The report of the January 2018 self-assessment revealed very many gaps to be addressed and hence placed the Agency on maturity level 1. The team worked tirelessly with the heads of Directorates to address the gaps identified and a great level of improvement has been made in all regulatory functions. This was indicated by the second more robust self- Benchmarking exercise conducted in October 2018 which showed a maturity level 2 for most regulatory functions with a possibility of transiting to maturity level 3.

In order to progress this programme further, the Director General requested a full benchmarking assessment from Regulatory Systems Strengthening (RSS) team of WHO Headquarters, Geneva for the year 2019.

The WHO self-assisted audit took place in April 2019.  In preparation for the full audit in June 2019, the Director General approved the organization of a Management Review Retreat to bring together relevant staff to collectively identify and address all deficiencies in levels 1-2 of the WHO Global Benchmarking process with a view to transiting to maturity level 3.

During the retreat, there was further review of the evidences with the ‘fact sheets’ for each regulatory function and relevant staff were charged to ensure that all identified gaps were closed before the June 2019 full audit.