| 基于“延伸检查”实施新版中药材GAP各方职责与机遇探讨 |
| 投稿时间：2022-04-06 点此下载全文
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| 引用本文：魏建和,王秋玲,王文全,乔旭.基于“延伸检查”实施新版中药材GAP各方职责与机遇探讨[J].中国现代中药,2022,24(5):752-757 |
| DOI：10.13313/j.issn.1673-4890.20220406001 |
| 摘要点击次数: 252 |
| 全文下载次数: 52 |
| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 魏建和* |
WEI Jian-he |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193
中国医学科学院 北京协和医学院 药用植物研究所 海南分所/海南省南药资源保护与开发重点实验室/ 国家中医药管理局沉香可持续利用重点研究室，海南 海口 570311 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China
Hainan Provincial Key Laboratory of Resources Conservation and Development of Southern Medicine & Key Laboratory of National Administration of Traditional Chinese Medicine for Agarwood Sustainable Utilization, Hainan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Haikou 570311, China |
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| 王秋玲 |
WANG Qiu-ling |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China |
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| 王文全 |
WANG Wen-quan |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China |
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| 乔旭 |
QIAO Xu |
中国医学科学院 北京协和医学院 药用植物研究所/中草药物质基础与资源利用教育部重点实验室/ 濒危药材繁育国家工程实验室，北京 100193 |
Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine, Ministry of Education & National Engineering Laboratory for Breeding of Endangered Medicinal Materials, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100193, China |
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| 基金项目:中国医学科学院医学与健康科技创新工程项目（2021-I2M-1-032）；财政部和农业农村部：国家现代农业产业技术体系项目；国家药品监督管理局委托研究课题（2019年）；国家中医药管理局委托办事课题（GZY-KJS-2018-016-01） |
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| 中文摘要:为有助于理解新发布的《中药材生产质量管理规范》（以下简称新版中药材GAP）实施的“延伸检查”方式、促进各方建设规范化生产基地、推动中药高质量发展，探讨按“延伸检查”实施新版中药材GAP中药生产企业、中药材生产企业及各相关管理部门的职责，及其带来的挑战和机遇等。新版中药材GAP既没有采取《中药材生产质量管理规范（试行）》采用的认证方式，也没有采用备案管理方式，而是采用了“延伸检查”的新方式。中药生产企业药品标签标示“药材符合GAP要求”，有责任开展原料供应商审核，省级药品监督管理部门对中药生产企业监管时可按需要延伸检查中药材生产企业，地方政府和各部门鼓励指导中药生产企业和中药材生产企业建设GAP基地。采用延伸检查实施新版中药材GAP可使中药材生产企业走上发展壮大之路，成为中药生产企业保障原料质量、生产优质药品的重要抓手，成为地方政府和中药行业管理部门发展中药材生产的有效手段，也将成为药品监督管理部门药材质量监管的有效方式。 |
| 中文关键词:新版《中药材生产质量管理规范》 “延伸检查” 中药材生产企业 中药生产企业 认证 备案管理 |
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| Responsibilities and Opportunities for Related Parties Based on the “Extended Inspection” in Good Agricultural Practice for Traditional Chinese Medicinal Materials |
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| Abstract:The paper aims to help understanding the extended inspection mode in the recently released Good Agricultural Practice for Traditional Chinese Medicinal Materials (new version GAP, nGAP), and encourage related parties to build GAP production bases and promote the high-quality development of traditional Chinese medicine (TCM). The responsibilities of TCM producers, traditional Chinese medicinal materials (TCMM) producers and other related administrative departments are discussed in accordance with the extended inspection mode of nGAP, and the resulting challenges and opportunities are also explored. nGAP adopts a novel mode, i.e., extended inspection, and abandons the authentication mode in the trial version GAP and the filing management mode. For drugs labeling "TCMM meets GAP requirements", TCM producers are required to carry out the audit of raw material suppliers. Provincial drug regulatory departments, when supervising TCM producers, can extend inspection to TCMM producers if necessary. Local government and related departments should encourage or guide TCM producers and TCMM producers to build GAP bases. The extended inspection in nGAP is expected to enhance the strength for TCMM producers and help TCM producers to safeguard raw materials quality and produce high-quality drugs. Moreover, this novel mode is a reliable measure for local governments or TCM administrative departments to develop the production of TCMM, and may be an effective way for drug regulatory departments to supervise the quality of TCMM. |
| keywords:new version Good Agricultural Practice for Traditional Chinese Medicinal Materials (GAP) "extended inspection" traditional Chinese medicine producers traditional Chinese medicinal materials producers authentication filing management |
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