[中药人体使用经验研究质量控制指南]。

Q3 Pharmacology, Toxicology and Pharmaceutics
Ya-Qin Tang, Zhong-Qi Yang, Zhao-An Tang, Wei-An Yuan, Jian-Yuan Tang, Chong Zou
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引用次数: 0

摘要

国家医药管理局于2023年2月发布了《中药注册管理特别规定》,鼓励在中药临床实践中开展高质量的人体使用经验(HUE)研究,为中药注册提供充分的证据支持。规定提出,"人体使用经验研究 "应符合相关要求,并接受药品注册核查。本文旨在规范HUE研究,获得高质量的HUE数据以支持注册申请,促进研究的规范化。根据国家有关法律法规和国家医药品监督管理局药品审评中心《人体使用经验研究技术指导原则》的要求,结合中药临床特点,中国药学会中药临床评价专业委员会组织制定了《中药人体使用经验研究质量控制指导原则》、包括开展人体使用经验研究的医疗机构条件、研究者、申办者、药学关键信息和要求、研究方案、伦理审查要点、研究实施过程要求、风险管理、人体使用经验研究的受试者保护等。经过多轮专家咨询,最终形成了适合支持药品注册、指导中药HUE研究的指导文件。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Guidelines for quality control of human use experience study on traditional Chinese medicine].

National Medical Products Administration released the Special provisions on the administration of registration of traditio-nal Chinese medicine(TCM) in February 2023, encouraging high-quality human use experience(HUE) study in TCM clinical practice to obtain sufficient evidence for TCM registration support. The provisions suggested that the HUE study should meet the relevant requirements and accept the drug registration verification. This paper aims to standardize the HUE study, obtain high-quality HUE data to support registration applications, and promote the standardization of research. In accordance with the relevant laws and regulations of the state and the requirements of the technical guidelines for the HUE study in the drug review center of the National Medical Products Administration, the clinical characteristics of TCM were considered, and the Clinical Evaluation Committee of Traditional Chinese Me-dicine of the Chinese Pharmaceutical Association organized and formulated the Guidelines for quality control of human use experience study on traditional Chinese medicine,including the conditions of medical institutions carrying out HUE study, researchers, sponsors, key information and requirements of pharmacy, research programs, key points of ethical review, requirements of the research implementation process, risk management, and subject protection of HUE study. After several rounds of consultation with experts, a guideline document suitable for supporting drug registration and guiding HUE study on TCM was finally formed.

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来源期刊
Zhongguo Zhongyao Zazhi
Zhongguo Zhongyao Zazhi Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
1.50
自引率
0.00%
发文量
581
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