中成药上市后临床评价的整体设计

通过对政策、市场和学术等方面的研究,分析中成药上市后临床再评价的现状和需求,归纳和整理当前存在的问题,对中成药上市后临床再评价整体设计的原则和基本思路进行探讨。通过整体设计,可以为中成药的中长期发展建立规划,确定研究周期、研究目标,研究步骤,将学术研究和市场拓展、经费投入等关联起来,从而高效高质的促进中成药的二次开发过程;通过整体设计,可以有效利用社会资源,进一步提高中成药上市后临床再评价的水平和质量,对相关产品的临床再评价提供建议和参考,促使上市后临床再评价更具有客观性、科学性、可行性和可信性。

Overall Design of Post-marketing Clinical Evaluation in Chinese Patent Medicine

To analyze the current situation and needs of the post-marketing clinical evaluation of Chinese patent medicine, summarize the existing problems, and discuss the principles and basic ideas of the overall design of the post-marketing clinical evaluation of Chinese patent medicine through the study of policy, market and academic research. Through overall design, to establish a middle-term and long-term development plan of the Chinese patent medicine, and to determine the research cycle, objectives and steps. The academic research, market development and funding can be integrated to promote secondary development of Chinese patent medicine efficiently with high quality. The overall design can promote utilization of the social resources effectively, further to improve the level and quality of the post-marketing clinical evaluation of Chinese patent medicine, providing recommendations and references to the post-marketing clinical evaluation of relevant products, and more importantly to promote post-marketing clinical evaluation more objective, scientific, feasible and credible.