Tailored to fit: China optimizes policies and regulations regarding drug registration and review to promote innovation in traditional Chinese medicine.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY
Drug Discoveries and Therapeutics Pub Date : 2024-09-19 Epub Date: 2024-07-20 DOI:10.5582/ddt.2024.01055
Daoran Lu, Fangzhou Dou, Fanghua Qi, Jianjun Gao
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引用次数: 0

Abstract

The classification system for drug registration and the review and approval process influence the innovation and development of pharmaceuticals. China's previous classification standards for registration of traditional Chinese medicines (TCMs) overly emphasized the material basis while neglecting the clinical value of TCM. Moreover, the review and approval system did not fully consider the characteristics of new TCM drugs, such as the clinical experience already available for many TCM formulations guided by TCM theories. This resulted in suboptimal quality and quantity in the development of new TCM drugs. Since 2019, China has introduced a series of policies and regulations aimed at reforming the classification system for registration of TCMs and establishing a review system tailored to TCM characteristics. The new classification system for registration of TCMs emphasizes that the development of new TCM drugs should be oriented towards clinical value, focusing on meeting unmet clinical needs. The policies and regulations promote the conversion of prescriptions in ancient classics into new drugs and encourages the conversion of preparations from medical facilities into new TCM drugs. Secondary development of already marketed TCM products is encouraged to enhance the advantages of their clinical use. The new review system places importance on the role of TCM theories and clinical experience in supporting the registration of new TCM drugs. These reform measures have paved a path for registration and review of the characteristics of TCMs and will positively promote the development of new TCMs.

量体裁衣:中国优化药品注册和审评政策法规,促进中药创新。
药品注册分类制度和审评审批程序影响着药品的创新和发展。中国以往的中药注册分类标准过于强调物质基础,忽视了中药的临床价值。此外,审评审批制度没有充分考虑中药新药的特点,如许多中药配方在中医理论指导下已有的临床经验。这导致中药新药研发的质量和数量都不尽如人意。2019 年以来,中国出台了一系列政策法规,旨在改革中药注册分类制度,建立符合中医药特点的审评制度。新的中药注册分类制度强调,中药新药研发应当以临床价值为导向,以满足未满足的临床需求为重点。政策法规提倡将古代经典处方转化为新药,鼓励将医疗机构制剂转化为中药新药。鼓励对已上市的中药产品进行二次开发,提升临床使用优势。新的审评制度重视中医理论和临床经验对中药新药注册的支撑作用。这些改革措施为中药特点注册审评铺平了道路,将积极促进中药新药的发展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Drug Discoveries and Therapeutics
Drug Discoveries and Therapeutics PHARMACOLOGY & PHARMACY-
CiteScore
3.20
自引率
3.20%
发文量
51
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