中国食品药品监管Issue(2)：92-103,12.DOI:10.3969/j.issn.1673-5390.2025.02.009
国内外疫苗批签发管理概述
Overview of Vaccine Lot Release Management at Home and Abroad
周雅洁 1聂建辉 2黄维金 2胡庆华 3贺鹏飞2
作者信息
- 1. 中国药科大学药学院||中国食品药品检定研究院||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||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
- 2. 中国食品药品检定研究院||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||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
- 3. 中国药科大学
- 折叠
摘要
Abstract
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Key words
vaccine/lot release/biological products/regulation/World Health Organization分类
医药卫生引用本文复制引用
周雅洁,聂建辉,黄维金,胡庆华,贺鹏飞..国内外疫苗批签发管理概述[J].中国食品药品监管,2025,(2):92-103,12.
