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

疫苗国家监管体系(NRA)评估是世界卫生组织(WHO)考察一个国家疫苗监管能力的重要举措和有效手段,通过此项评估意味着一个国家和地区拥有稳定、运行良好且完整统一的监管体系,能确保其生产或流通的疫苗质量可控、安全、有效。2022年,我国迎来WHO升级评估标准后的新一轮全面评估。此次评估工作共涉及9个板块,其中,监督检查(RI)板块是疫苗NRA评估中最受关注、最为关键的板块之一,其与保证疫苗质量密切相关。本文介绍了RI板块的基本情况,结合疫苗监督检查工作现状对该板块6项主指标、26项亚指标进行分析解读,并在此基础上提出促进我国疫苗监督检查工作的建议。

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.