| 徐宏山,李玉华.用于国家监管体系评估的WHO全球基准工具介绍及其应用进展[J].中国药事,2024,38(1):1-10 |
| 用于国家监管体系评估的WHO全球基准工具介绍及其应用进展 |
| Introduction and Application Progress of WHO Global Benchmarking Tool |
| 投稿时间：2022-12-28 |
| DOI：doi:10.16153/j.1002-7777.2024.01.001 |
| 中文关键词: 疫苗 世界卫生组织 国家监管体系 全球基准工具 NRA评估 |
| 英文关键词: vaccine world health organization national regulatory system global benchmarking tool NRAassessment |
| 基金项目: |
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| 中文摘要: |
| 目的：对世界卫生组织（World Health Organization，WHO）用于国家监管体系（NationalRegulatory Authorities，NRA）评估的全球基准工具（Global Benchmarking Tool，GBT）及基准流程进行介绍和深入研究，旨在帮助相关人员进一步了解WHO关于NRA评估的新的具体要求，进一步推动医疗产品检验检测和疫苗批签发管理水平提高。方法：介绍GBT框架，对GBT 9大板块进行分析汇总，研究WHO采用GBT进行NRA评估的流程和应用进展以及对我国的启示。结果与结论：GBT针对国家监管体系9大职能板块分别设置一系列指标和268个亚指标进行评估，并引入4级成熟度级别（Maturity Level，ML）的概念；正式基准过程包括提交意向书、对意向书评估、就评估范围和路线图达成协议、正式评估、宣布决定和列名等5个步骤；截至2022年10月，WHO宣布共有12个国家通过了以GBT为基准的NRA评估。我国疫苗NRA评估已达到ML3水平，但仍需深入改进，向ML4水平继续努力。 |
| 英文摘要: |
| Objective: To help relevant personnel to further understand the new specifi c requirements of WorldHealth Organization (WHO) on National Regulatory Authorities (NRA) assessment, and further promote themanagement level of medical product inspection and testing and vaccine batch issuance by introducing anddeeply studing on the Global Benchmarking Tool (GBT) and benchmarking process used by the WHO forNRA evaluation. Methods: The article introduced the GBT framework, analyzed and summarized the ninemajor sections of GBT, and studied the process and application progress of WHO's adoption of GBT for NRAassessment, and its enlightenment to China. Results and Conclusion: The GBT tool set a series of indicatorsand 268 sub-indicators to evaluate the nine functional sections of the national regulatory system, and introducedthe concept of 4-level maturity level (ML); the formal benchmarking process included fi ve steps: submitting aletter of intent, assessing the letter of intent, reaching an agreement on the scope and roadmap of the assessment,conducting a formal assessment, announcing a decision, and listing; as of October 2022, the WHO has announcedthat a total of 12 countries have passed the NRA assessment based on GBT. The NRA assessment of vaccines inour country has reached the ML3 level, but it still needs further improvement and continuous eff orts to reach theML4 level. |
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