国内外疫苗批签发管理概述  

Overview of Vaccine Lot Release Management at Home and Abroad

作　　者：周雅洁 聂建辉[2,3,4] 黄维金 胡庆华[5] 贺鹏飞 ZHOU Ya-jie;NIE Jian-hui;HUANG Wei-jin;HU Qing-hua;HE Peng-fei(School of Pharmacy,China Pharmaceutical University;National Institutes for Food and Drug Control;Key Laboratory of Biotechnology Product Testing Methods and Standardization of National Health Commission;Key Laboratory of Biological Product Quality Research and Evaluation of NMPA;China Pharmaceutical University)

机构地区：[1]中国药科大学药学院 [2]中国食品药品检定研究院 [3]国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室 [4]国家药品监督管理局生物制品质量研究与评价重点实验室 [5]中国药科大学

出　　处：《中国食品药品监管》2025年第2期92-103,共12页China Food & Drug Administration Magazine

摘　　要：疫苗与人类健康息息相关,其安全性、有效性和质量可控性至关重要。疫苗批签发是疫苗监管的重要制度,世界各国和地区对疫苗批签发管理存在共性和差异。各国和地区依据世界卫生组织相关规定及本国和地区法律法规建立相应的监管制度和工作机制,以确保上市疫苗的质量安全。本文通过对国内外疫苗批签发的管理方式进行梳理与分析,以了解各国和地区批签发管理的现状和发展趋势。Vaccines are closely related to human health,making their safety,effectiveness,and quality controllability of great importance.The lot release of vaccines is a critical regulatory system,and there exist both commonalities and differences in its management among various countries and regions.Each country establishes its own regulatory system and operational mechanism based on relevant World Health Organization(WHO)regulations as well as domestic laws and regulations to ensure the quality of marketed vaccines.This article sorts out and analyzes the management methods for vaccine lot release in different regions,aiming to understand the current situation and development trends in lot release management worldwide.

关 键 词：疫苗 批签发 生物制品 监管 世界卫生组织 

分 类 号：R95[医药卫生—药学]