基于“延伸检查”分析新版《中药材生产质量管理规范》实施中存在的问题及建议  

Problems and Suggestions in the Implementation of the New Version of GAP Based on the″Extended Inspection″

作　　者：邓婷 白小琼 叶静 李青 樊卫 DENG Ting;BAI Xiaoqiong;YE Jing;LI Qing;FAN Wei(Chongqing Center for Drug Evaluation and Inspection,Chongqing,China 401120)

机构地区：[1]重庆市药品技术审评查验中心,重庆401120

出　　处：《中国药业》2025年第7期7-11,共5页China Pharmaceuticals

摘　　要：目的为推进新版《中药材生产质量管理规范》(GAP)实施“延伸检查”提供参考。方法基于“延伸检查”视角,分析新版GAP的政策变化,以及实施中可能存在的问题,并提出有针对性的建议。结果与结论新版GAP的建设主体为企业,以市场为导向,推进简政放权,制订激励政策。但目前在中药材基原、种植环境、规模化条件、种植(养殖)投入品管理、标准文件制订来源、追溯要求、人员要求等方面仍存在问题。建议现阶段适当放宽中药材基原要求,建立生态稳定的种植环境,依法管理种植(养殖)投入品,结合已颁布的标准、规范制订标准文件,保证满足可追溯要求,加强专业技术人员培养,以促进新版GAP顺利落地实施和产业可持续发展。Objective To provide a reference for promoting the implementation of″extended inspection″of the new version of Good Agricultural Practice for Traditional Chinese Medicinal Materials(GAP).Methods Based on the perspective of″extended inspection″,the policy changes of the new version of GAP and the problems in the implementation were analyzed,and targeted suggestions were put forward.Results and Conclusion In the new version of GAP,the construction subject is enterprises with market-oriented,it promotes streamlining administration and delegating power,and formulates incentive policies.However,there are still some problems in the origin of traditional Chinese medicinal materials,planting environment,scaling conditions,management of planting(breeding)inputs,sources of standard documents,traceability requirements,personnel requirements,and so on.It is suggested to appropriately relax the requirements for traditional Chinese medicinal materials at this stage,establish an ecologically stable planting environment,manage planting(breeding)inputs in accordance with the law,formulate standard documents based on already issued standards and specifications,ensure traceability requirements,strengthen the training of professional and technical personnels,and promote the smooth implementation of the new version of GAP and sustainable development of the industry.

关 键 词：“延伸检查” 中药材 生态种植 道地药材 追溯体系 

分 类 号：R932[医药卫生—生药学] R288[医药卫生—药学]