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作 者:杨光[1] 郭兰萍[1] 周修腾[1] 黄璐琦[1]
机构地区:[1]中国中医科学院中药资源中心道地药材国家重点实验室培育基地,北京100700
出 处:《中国中药杂志》2016年第7期1173-1177,共5页China Journal of Chinese Materia Medica
基 金:国家自然科学基金项目(81130070);国家科技支撑计划项目(2012BAI29B02;2012BAI28B002)
摘 要:该文回顾了中药材GAP产生的历史背景,分析了5个P(GMP,GLP,GSP,GCP,GAP)发展的经验,应用经济学理论对中药材GAP进行了分析,指出中药材GAP遇到问题的核心是忽略经济规律,曾经的中药材GAP是过程认证,GAP公告无法形成质量信号在产品市场中传递,消费者无法在终端市场找到GAP与非GAP药材的区别,厂商缺乏GAP认证的动力。该文提出了应在经济学的指导下,重新设计GAP的认证制度,由第三方认证机构承担认证,将GAP定位为优质标准,药监部门的角色从许可基地到监督和管理第三方认证机构,提出完善GAP认证的信号传导机制,实现GAP与市场的接轨。This paper reviewed the historical background of the GAP,analyzed the development experience of five Ps( GMP,GLP,GSP,GCP,GAP),analyzed the GAP based on economic theories,and pointed out that the core problem of GAP is ignoring economic laws. Once the GAP,is a process of certification,but neither the GAP announcement could be transformed into signal transmission quality in the product market,nor consumers could recognize the difference between GAP and non-GAP herbs in the terminal market,so manufacturers lack motivation for GAP certification. In this paper,we pointed out,that the GAP certification system should be redesigned under the guidance of economics,third party certification body,supervised by drug administration organization,to certificate GAP as high quality standards,to improve signal transduction mechanism of GAP certification,and to integrate GAP with the market.
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