基于国际物品编码组织标准的出口疫苗追溯标识系统的应用进展

Application progress on export vaccine traceability labeling system based on Global Standard 1

COVID-19是由SARS-CoV-2感染引起的一种呼吸道疾病,具有较强的传染力,严重威胁人类健康,接种疫苗是预防SARS-CoV-2感染最有效的手段。世界卫生组织(World Health Organization,WHO)要求使用国际物品编码组织(Global Standard 1,GS1)标准实现对新型冠状病毒疫苗(简称新冠疫苗)和治疗制剂的跟踪与追溯。追溯标识系统是追溯系统的基础和核心,是实施追溯的前提,贯穿于整个产品追溯过程中。通过对出口疫苗产品各级包装及物流单元进行全球唯一性编码、建立疫苗追溯码和物流单元追溯码标识,帮助出口疫苗生产企业建立追溯制度,实现产品生产、流通、使用等环节信息的追溯,可强化出口疫苗产品质量安全监管、风险监测预警和有效处置、问题产品召回及原因分析,增强国际市场对中国疫苗安全的信任与认可。本文对出口疫苗产品建立追溯制度的重要性、GS1系统在国内外医疗领域的应用、出口疫苗产品追溯标识编码、条码表示及质量要求作一综述,以期为我国出口疫苗产品建立追溯标识制度,满足国际标准法规要求提供参考。

COVID-19 is a respiratory disease caused by SARS-CoV-2 infection,which has strong infectivity and seriously threatens human health all over the world.Vaccination is the most effective means to prevent SARS-CoV-2 infection.World Health Organization(WHO)has required the use of Global Standard 1(GS1)for the tracking and traceability of COVID-19 vaccines and therapeutics.Traceability identification system is the basis and core of traceability system,as well as the premise of implementation of traceability,throughout the whole product traceability process.By carrying out unique global coding for all levels of packaging and logistics units of export vaccine products,and establishing vaccine traceability codes and logistics unit traceability codes,we can help export vaccine manufacturers establish traceability systems,realize the traceability of product information in production,circulation,use and other links,strengthen the quality and safety supervision of export vaccine products,strengthen the risk monitoring,early warning and effective disposal,as well as strengthen the recall of defective products and analysis of causes,so as to enhance the international market´s trust and recognition of Chinese vaccine safety.This paper summarizes the importance of establishing traceability system for export vaccine products,the application of GS1 system in medical field at home and abroad,the traceability identification coding,barcode representation and quality requirements of export vaccine products,in order to provide a reference for establishing traceability identification system for export vaccine products in China and meeting the requirements of international standards and regulations.