Abstract：
The establishment of core indicators for assessment plays an important role in carrying out the lifecycle value assessment of Chinese patent medicine, which are developed based on the concepts such as clinical value oriented, paying attention to the human use experience, and whole process quality control. To this end, the Specialty Committee of Data Monitoring and Decision Making of the World Federation of Chinese Medicine Societies organized experts to draft the Expert Consensus on Core Indicators for Lifecycle Value Assessment of Chinese Patent Medicine based on the research including Chinese Medicine Registration Review Evidence System in Combination of Traditional Chinese Medicine Theory, Human Use Experience, and Clinical Trials(GZY-FJS-2022-206) by National Administration of Traditional Chinese Medicine. This consensus proposed 92 core indicators from four stages, including new drug R&D project approval, pre-clinical research, new drug marketing authorization, and post-marketing, combining the assessment purposes and needs of different stakeholders from different dimensions such as clinical needs, clinical positioning, human use experience, effectiveness, safety, quality control, innovation, accessibility, and suitability. This consensus also interpreted the indicators to clearly elucidate the core elements of the value assessment of Chinese patent medicine in different R&D stages and guided the stakeholders to identify, analyze, and assess the value of Chinese patent medicine in the R&D and use process based on the core indicators in a scientific, objective, and standardized approach. This consensus is expected to play an important role in the high-quality new drug development, drug pricing and compensation of Chinese patent medicine, the development of clinical pathways, and rational clinical application.
摘要：
评估核心指标的建立对开展中成药生命周期价值评估具有重要作用,它是基于临床价值导向等概念开发的，关注人类的使用经验，和全过程质量控制。为此,世界中医药学会联合会数据监测与决策专业委员会组织专家在中药注册评审证据体系结合中医理论研究的基础上,起草了《中成药生命周期价值评估核心指标专家共识》,人类使用经验,和临床试验（GZY-FJS-2022-206）由国家中医药管理局。这一共识从四个阶段提出了92项核心指标，包括新药研发项目批准，临床前研究,新药上市许可,和后营销，结合临床需求等不同维度的不同利益相关者的评估目的和需求，临床定位,人类的使用经验，有效性,安全,质量控制,创新,可访问性,和适用性。这一共识还对指标进行了解读,明确阐明了中成药在不同研发阶段价值评估的核心要素,分析,并根据核心指标对中成药在研发和使用过程中的价值进行评估,目标,标准化方法。这一共识有望在高质量新药开发中发挥重要作用,中成药的药品定价与补偿,临床路径的发展，和合理的临床应用。
