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Stakeholders Meeting on Implementation of Pharmaceutical Traceability & Other Pertinent Issues


February 8, 2023,

The Director General, Professor Mojisola Adeyeye and some staff members met with major stakeholders in the pharmaceutical industry, comprising of pharmaceutical manufacturers and importers, on the 6th of February to discuss the introduction of Pharmaceutical Traceability and the use of GS1 technology for monitoring product movement through the pharmaceutical supply chain in the country.

The meeting, which was held at the Radisson Blu Hotel in Ikeja, Lagos, was well attended by members of PMGMAN, APIN, IPMIN and NIROPHARM. The meeting, which was a hybrid of physical and virtual components, also had in attendance, the CEO of GS1, Tunde Odunlami and some Solution Providers, amongst which are Chekkit Technology, m-Pedigree, Newsoft Technology, and Sproxil. 

In her opening remarks, the newly reappointed DG, whose tenure was renewed on the 1st of December 2022, started the meeting by outlining her vision and agenda for her second term in office. She highlighted that her main goal for her second tenure is ensuring that NAFDAC maintains her Maturity Level 3 Status which was awarded by the WHO in March last year. She added that the ultimate goal was the achievement of Maturity Level 4 (ML 4) with the World Listed Authority (WLA) status. She also stated that restructurings are currently on-going (for Senior and Junior staff members) to meet with identified gaps in the Agency’s regulatory systems strengthening plan. She reinforced her commitment to support the growth of the pharmaceutical industry sector in Nigeria with the introduction of innovative reforms like the GMP roadmap exercise, the 5+5 local content policy (aimed at transferring of technology to local manufacturers), use of Track and Trace technology (to stamp out substandard and falsified medicines and other pharmaceutical products), Good Distribution Practice (GDP) inspections, as well as the introduction of Dossier Management System, an online solution that streamline the dossier review.

Key issues presented by different speakers during the different sessions include key interventions to the pharmaceutical dossier submission and review process, Nigeria’s Roadmap to attaining WHO Prequalification of local drug manufacturing facilities, Rationale for introduction of GDP Inspections and use of Track and Trace Technology as well as local Active Pharmaceutical Ingredient (API) manufacturing and Vaccines development in Nigeria.

The DG NAFDAC brought the meeting to a close by re-emphasizing the need for all pharmaceutical product manufacturers and importers to “know their chain” and appealed to the industry to join hands with the Agency in the fight against counterfeiting, and substandard and falsified medicines in order to reduce the prevalence of treatment failure and high morbidity caused by their presence in the pharmaceutical supply chain in Nigeria.

All presentations and slides can be accessed via the links included therein.

  1. NAFDAC Pharma Stakeholder Engagement
  2. Stakeholder Engagement on Implementation of Pharmaceutical Traceability
  3. Dossier Management System
  4. Overview of Bioequivalence and Regulatory Submission
  5. Nigeria’s Journey Implementing Pharmaceutical Traceability Using GS1 Standards

NAFDAC………….Safeguarding the Health of the Nation!!!

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