试论医疗机构中药制剂全生命周期管理

中医药理论-人用经验-临床试验相结合（以下简称三结合）的中药注册审评证据体系作为中药审评审批改革的关键,越来越受到业界的重视。医疗机构制剂来源于临床,具备人用经验的载体特性,具有开展新药转化的先天属性,亦成为人用经验收集和应用的重要节点。基于“三结合”的审评证据体系,对医疗机构制剂实施全生命周期管理,可以解决现阶段医疗机构中药制剂研发、使用、转化过程中存在的普遍性问题,从而实现医疗机构制剂在满足临床需求、良性发展的基础上,发挥其人用经验收集、传承创新发展“孵化器”的作用。

Whole Life Cycle Management of Traditional Chinese Medicine Preparations in Medical Institutions

The traditional Chinese medicine (TCM) registration and evaluation evidence system with the combination of "TCM theories, experience in human application and clinical trials" (referred to as "three combinations") is crucial to the TCM review and approval reform, and has therefore attracted more attention of the industry. The preparation of medical institutions derived from the clinic has the carrier characteristics of human experience and the innate property of transforming new drugs, becoming an important node for the collection and application of experience in human application. Based on the "three combinations" system, the whole life cycle management can solve the universal problems existing in the research and development, use and transformation of TCM preparations in medical institutions at present. Moreover, by satisfying clinical needs and benign development, preparations in medical institutions can play the role of "incubator" for the collection, inheritance, innovation and development of experience in human application.