疫苗流通全程监管中的追溯数据验证和数据扩展探讨

Discussion on Tracing Data Verification and Expansion in the Whole Process Supervision of Vaccine Distribution

疫苗流通安全关系百姓接种安全,疫苗流通过程的质量安全是决定达到接种单位的疫苗质量安全的关键,而追溯是对疫苗流通过程跟踪和监管的最佳手段。《疫苗管理法》第五条和第十条对疫苗追溯进行了明确规定,国家药品监督管理局疫苗追溯协同服务平台已经完成了上市许可持有人追溯数据和疾病预防控制机构追溯数据的交换,各级监管部门也针对疫苗流通过程建立了以流向为核心的监管系统。目前的追溯是以流向为核心,对流通过程的作业过程、质量控制等涉及不多,通过现有追溯体系实现对疫苗流通过程和质量风险的监管还有所不足。本文通过对疫苗流通全业务过程的分析,依托于国药控股上海生物医药有限公司的疫苗业务,探讨了满足疫苗特征的追溯数据验证方法和在现有追溯数据基础上对疫苗供应链-物流作业过程、质量控制等方面的扩展,有利于监管部门在疫苗流向监管的基础上,通过追溯数据以数字化方式实现对业务过程的规范性、高质量的监管。

The safety of vaccine distribution is related to the safety of public vaccination.The quality and safety of the vaccine distribution process is the key to determining the quality and safety of vaccines reaching vaccination sites,and traceability is the best way to track and supervise the vaccine distribution process.Articles 5 and 10 of the Vaccine Administration Law clearly stipulate the traceability of vaccines.The vaccine traceability collaborative service platform of the National Medical Products Administration has completed the exchange between traceability data of marketing license holders and disease prevention and control institutions.The regulatory authorities at all levels have also established a regulatory system centered on the flow of vaccines for the distribution process.The current traceability is based on the flow direction,and there is not much involvement in the operation process and quality control of the distribution process.It is still insufficient to realize the supervision of the vaccine distribution process and quality risk through the existing traceability system.Based on the analysis of the whole process of vaccine distribution and relying on the vaccine business of Sinopharm Holding Shanghai Biopharmaceutical Co.,Ltd.,this paper discusses the traceability data verification method that meets the characteristics of vaccines and the expansion on vaccine supply chain-logistics operation process and quality control,etc.based on the existing traceability data.On the basis of the supervision of vaccine flow,the regulatory authorities can realize standardized and high-quality supervision of the business process in a digital way through traceability data.