随着我国新药审评制度的日趋完善和新技术的广泛应用，中医药事业迎来了天时、地利、人和的大好发展时机。在未来的新药研发中，需要更加重视和有效发掘古代文献和临床用药经验，采用中药新药的临床疗效研究数据建立相应证候的评价指标体系已成为普遍认同的趋势。科学地深入认识中药的安全性，不断完善中药新药注册分类方法和改进新药评审方式已成为未来的研究方向。我们需要结合现代药品研发、评价标准，总结近30年中药新药审评的经验，积极探索建立并完善符合中药特点的审评注册技术体系，这对中医药服务临床和产业发展具有重要意义。

Thanks to the improving new drug approval system and the wide application of new technology in China,the development of traditional Chinese medicine(TCM)meets the golden opportunity at the best conditions.In the further research of new drugs,effective data mining of ancient literatures and clinical medication experience need paying more attention supported by research data of clinical efficacy of new Chinese drugs,as it is generally recognized,for the establishment of the approval system of syndrome types.In addition,we should prudently value the safety issues on TCM and improve the classification and registration of new Chinese drugs and drug approval in the future.Therefore,the research and development of modern drugs,evaluation standard and review experience of new Chinese drugs in the recent three decades need integrating for the establishment of the improvement of the technology system of drug review and registration in conformity with the characteristics of TCM of great significance in the clinical service and industrial development of TCM.

本文是张伯礼院士在"药审中心关于探索构建适合中药特点的技术标准体系座谈会"上的讲话，大会相关文章详见本期P2070-P2104。