Yang Guang, Guo Lan-Ping, Zhou Xiu-Teng, Huang Lu-Qi
State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2016 Apr;41(7):1173-1177. doi: 10.4268/cjcmm20160702.
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.
本文回顾了中药材生产质量管理规范(GAP)的历史背景,分析了五个“P”(药品生产质量管理规范GMP、药物非临床研究质量管理规范GLP、药品经营质量管理规范GSP、药物临床试验质量管理规范GCP、中药材生产质量管理规范GAP)的发展历程,基于经济理论对GAP进行了分析,并指出GAP的核心问题是忽视经济规律。曾经,GAP是一个认证过程,但GAP公告既无法在产品市场转化为质量信号传递,终端市场的消费者也无法识别GAP与非GAP药材之间的差异,因此制造商缺乏进行GAP认证的动力。在本文中我们指出,应在经济学指导下重新设计GAP认证体系,由药品监管机构监督第三方认证机构,将GAP认证为高质量标准,完善GAP认证的信号传导机制,并使GAP与市场接轨。