政策法规

我国疫苗流通管理法律法规浅析

  • 周振歆 ,
  • 赵冰心 ,
  • 苗睿 ,
  • 董弋
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  • 1中国医学科学院医学生物学研究所, 昆明 650118; 2中国医学科学院医学生物学研究所质量保证部, 昆明 650118

网络出版日期: 2025-08-16

基金资助

云南省重大科技专项计划(202202AA100001)

Analysis on the laws and regulations of vaccine circulation management in China

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  • 1 Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650118,China;2 Quality Assurance Department,Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming 650118,China

Online published: 2025-08-16

Supported by

Yunnan Province Major Science and Technology Special Project (202202AA100001)

摘要

疫苗是含有生物活性物质的特殊药品,疫苗的储存和运输对温度有一定的冷链要求。山东疫苗案件之后国家陆续发布了一系列法律法规,进一步加强疫苗的生产、流通、接种管理。此文对疫苗流通管理相关的法律法规按时间顺序进行系统梳理和分析,旨在为疫苗生产、配送、储存企业以及接种单位等理清法律法规脉络,为其更好地开展疫苗流通管理提供法律法规依据。

本文引用格式

周振歆 , 赵冰心 , 苗睿 , 董弋 . 我国疫苗流通管理法律法规浅析[J]. 国际生物制品学杂志, 2025 , 48(1) : 55 -59 . DOI: 10.3760/cma.j.cn311962-20240730-00053

Abstract

Vaccine is a special drug containing bioactive substances, and the storage and transportation of vaccine have certain cold chain requirements on temperature. After the Shandong vaccine case, a series of laws and regulations have been issued to further strengthen the management of vaccine production, circulation and vaccination. In this paper, the laws and regulations related to vaccine circulation management are systematically combed and analyzed in chronological order, aiming at clarifying the context of laws and regulations for vaccine production, distribution, storage enterprises and vaccination agencies, and providing legal and regulatory basis for them to better carry out vaccine circulation management.
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