基于药品全生命周期的中药监管模型的构建研究

Research on construction of traditional Chinese medicine supervision model based on drug life cycle

随着2020版《药品管理法》正式增设药品上市许可持有人(marketing authorization holder,MAH)制度、药品监管科学行动计划以及《关于结束中药配方颗粒试点工作的公告》的正式实施,标志着中药正式进入全生命周期监管时代。当前,我国尚未能建立起一个符合中药规律和发展特点的全生命周期中药监管体系,中药产品疗效不稳定,我国的中医药产品安全性和使用有效性难以取得国际市场的重视和认可。因此,迫切需要建立一套全生命周期的中药监管体系,加强对中药的科学监管来推动其高质量发展。结合我国中药全生命周期实际监管中存在的问题,提出研制、生产、流通、使用环节指标,构建科学的中药全生命周期监管的评价体系,采用基于模糊群决策的评价方法科学评价各因素,以期规范中药全生命周期监管,促进中药质量标准与国际接轨。

With the official addition of the drug marketing authorization holder(MAH)system,the scientific action plan for drug supervision and the official implementation of the announcement on ending the pilot work of traditional Chinese medicine formula granules in the drug administration law of 2020,it marks that traditional Chinese medicine has officially entered the era of full life cycle supervision.At present,China has not yet established a full life cycle traditional Chinese medicine supervision system in line with the laws and development characteristics of traditional Chinese medicine,the curative effect of traditional Chinese medicine products is unstable,and the safety and use effectiveness of traditional Chinese medicine products in China are difficult to obtain the attention and recognition of the international market.Therefore,it is urgent to establish a full life cycle supervision system of traditional Chinese medicine and strengthen the scientific supervision of traditional Chinese medicine to promote its high-quality development.Combined with the pain points and blocking points of the actual supervision of the whole life cycle of traditional Chinese medicine in China,this paper puts forward the indicators of development,production,circulation and use,constructs a scientific evaluation system of the whole life cycle supervision of traditional Chinese medicine,and uses the evaluation method based on Fuzzy Group decisionmaking to scientifically evaluate various factors,in order to standardize the whole life cycle supervision of traditional Chinese medicine and promote the quality standard of traditional Chinese medicine in line with international standards.