中药复方新药研究的质量设计、质量完善与技术审评的分阶段要求

Quality design, quality improvement and evaluation requirement by stages on new traditional Chinese medicine compound preparation

中药复方是中医药文化的精髓,是中医临床用药的主要形式和手段,是中药新药研究和申报的主要类别和方向,是中医药文化"传承与发展"的重要内容,体现了中药特色的主要方面。结合多年的审评工作实践,浅谈对中药复方新药研究路径、研究规律的认识,以及对中药复方新药药学研究工作的要求,认为中药复方新药药学研究过程是一个质量设计、质量完善的过程,阐述了中药复方新药药学分阶段要求的审评认识;指出对中药复方新药研发路径、研发规律、研发策略乃至审评策略的讨论,有利于完善符合中药特点的技术审评标准体系,提高中药新药研发能力,促进中药新药创新研究,加快中药新药上市。

Chinese materia medica（CMM） compound is the quintessence of traditional Chinese medicine culture, the main form and method of clinical medicine of CMM, the main categories and direction of the research and registration of new CMM products, the important part of ＂inheritance and development＂ of CMM culture, and mainly reflects the characteristics of CMM. According to the evaluation practice for many years, the research path and the knowledge of the research rules for new drugs of CMM compound were discussed, and the requirements for pharmaceutical research works of new CMM compound preparation. The pharmaceutical research on new CMM compound preparation is a process of quality design and quality improvement. The evaluation requirements of different stages for new CMM compound preparation were elaborated. It is the conclusion that the discussion of RD path, RD law, and RD strategy on new CMM compound preparation will improve the technical evaluation standard system with the characteristics of CMM, increase the ability of RD for CMM new products, promote the innovation of CMM, and accelerate the new CMM products to go on market.