Regulatory Cooperation in Vaccines in Asia-Pacific Region

Lacey, Simon; Mitchell, Andrew D.

doi:10.2139/ssrn.4217244

Cited by 1 publication

(1 citation statement)

References 12 publications

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“…Global supports Vaccine traceability has become a focal point in global health initiatives, with various organizations emphasizing the importance of secure and transparent supply chains. Collaborative efforts and support involving entities like the World Health Organization (WHO), Pan American Health Organization (PAHO), Association of Southeast Asian Nations (ASEAN), and the Medicines and Healthcare products Regulatory Agency (MHRA) underscore the commitment to ensuring the safety and e cacy of vaccines on a global scale [5].…”

Section: Nafdac Strategies For Enhancing Vaccine Traceability In Nigeriamentioning

confidence: 99%

Traceability for Strengthening Supply Chain Systems and Enhancing Real-Time Visibility: Focus of NAFDAC on Advancing Vaccines Traceability in Nigeria

Adeyeye,

Kayode,

OLASUPO

2024

Preprint

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This study explores the successful implementation of activities aimed at scaling traceability for COVID-19 and Routine Immunization (RI) vaccines to the Local Government Level (LGA) and selected Healthcare facilities in Nigeria, funded by the Bill and Melinda Gates Foundation. The study was executed by the National Agency for Food and Drug Administration and Control (NAFDAC) and sought to enhance supply chain systems by deploying advanced traceability mechanisms, underscoring product monitoring, and ensuring real-time stock visibility. The inquest discusses the accomplishments, challenges, and regulatory framework of NAFDAC, emphasizing GS1 Technology-driven Traceability, and presents the outcome of the field scanning activities conducted in July 2023. The study utilized GS1 standards to uniquely identify products, locations, and personnel in the supply chain. The approach involved a phased public sector pilot, showcasing the feasibility and challenges of tracking vaccine movement through the supply chain. The result shows the detection of 43 unique products across 1022 facilities from a total of 110,113 scans, offering valuable insights into vaccine distributions. The strategic goals of the project aligned with developing safety surveillance systems in Low- and Middle-Income Countries (LMICs) to facilitate patient access to global health products. The safety surveillance initiative complemented ongoing global efforts among WHO-HQ, PAHO, ASEAN, and MHRA, underlining safety systems across regions. Similarly, a significant improvement in traceability through automated data capture (barcode scanning) and expanded coverage for COVID-19 and selected RI vaccines in Nigeria was recorded. Summarily, information derived from this report will build confidence in patients regarding vaccine authenticity, establish a transparent and robust supply chain, and foster pharmacovigilance capability through integration with the track-and-trace systems. Thus, the study provides invaluable insights and opportunities for global health practitioners, policymakers, and researchers. Convincingly, this script will also serve as a reliable blueprint and innovative model for incorporating track-and-trace into regulatory oversight by other National regulatory authorities, most especially in Low- and Middle-Income Countries.

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Section: Nafdac Strategies For Enhancing Vaccine Traceability In Nigeriamentioning

confidence: 99%