中国食品药品监管Issue(11)：18-27,10.DOI:10.3969/j.issn.1673-5390.2023.11.003
WHO疫苗国家监管体系评估监督检查板块指标解读
Interpretation of Indicators of Regulatory Inspection(RI)Function in WHO's Assessment of the National Regulatory Authority for Vaccines
黄兴 1黄健 2操桂兰 3周帅 4侯振华 5叶家辉4
作者信息
- 1. 山东省食品药品审评查验中心
- 2. 甘肃省药品监督管理局
- 3. 苏州工业园区药品管理中心
- 4. 国家药品监督管理局
- 5. 辽宁省药品监督管理局
- 折叠
摘要
Abstract
The assessment of the National Regulatory Authority(NRA)is an important and effective measure undertaken by the World Health Organization(WHO)to evaluate a nation's vaccine regulatory capacities.This assessment signifies that a country possesses a stable,well-functioning,and fully integrated vaccine regulatory system,ensuring the quality,safety,and effectiveness of vaccines manufactured,imported,or distributed within its borders.In July 2022,China's vaccine regulatory system underwent a new round of comprehensive assessment under the upgraded WHO evaluation standards.It involves evaluation of nine regulatory functions,among which the Regulatory Inspection(RI)function is one of the most critical and closely related to ensuring vaccine quality,thus attracted significant attention.This article introduces the basic information of the RI function,interprets and analyzes the 6 main indicators and 26 sub-indicators in combination with the current situation of vaccine inspection,and puts forward suggestions on enhancing regulatory inspection in China.关键词
疫苗监管体系/监督检查板块/指标/成熟度Key words
vaccine regulatory system/regulatory inspection function/indicators/maturity level分类
医药卫生引用本文复制引用
黄兴,黄健,操桂兰,周帅,侯振华,叶家辉..WHO疫苗国家监管体系评估监督检查板块指标解读[J].中国食品药品监管,2023,(11):18-27,10.
