玄振玉

    摘 要 比较以往《药品注册管理办法》3个主要版本，对2020年版的《中药注册专门规定(征求意见稿)》作了深入的分析，认为该规定特色鲜明，以临床价值为导向并充分重视人用药经验，契合中医药特色，对中药新药研发具有重要的指引作用。

    关键词 中药注册 临床价值 创新

    中图分类号：R288 文献标志码：C 文章编号：1006-1533(2021)01-0003-03

    Ten characteristics of the new version of traditional Chinese medicine registration management regulations

    XUAN Zhenyu*

    (Suzhou Youseen New Drug R&D Co.， Ltd.， Jiangsu Suzhou 215123， China)

    ABSTRACT An in-depth analysis of the 2020 version of the “Special Provisions for the Registration of Traditional Chinese Medicines (Draft for Solicitation of Comments)” was performed comparing the previous three main versions of the“Administrative Measures for Drug Registration”. It is believed that the regulation has distinctive features， are clinically valueoriented and pay full attention to the experience of human medicine， fully embody the characteristics of traditional Chinese medicine and play an important guiding role in the development of new traditional Chinese medicines.

    KEy WORDS traditional Chinese medicine registration； clinical value； innovation

    自1998年国家药品监督管理局(以下简称为“国家药监局”)成立以来 ......