孙昱.中国香港与中国内地中药注册分类及技术性申报资料要求的对比[J].药物评价研究,2019,42(8):1503-1508
中国香港与中国内地中药注册分类及技术性申报资料要求的对比
Comparison of registration classification and technical application materials between Hong Kong and mainland of China
投稿时间:2019-03-13  
DOI:10.7501/j.issn.1674-6376.2019.08.003
中文关键词:  中药注册;古方;经典名方;中药注射剂;中西药复方制剂
英文关键词:registration of traditional Chinese medicine;ancient prescription;classical prescription;Chinese medicine injection;Chinese and western medicine compound preparation
基金项目:
作者单位
孙昱 国家药品监督管理局 药品审评中心, 北京 100022 
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中文摘要:
      中药新药的注册申报涉及多种情况,其中中药经典名方、中药注射剂、中西药复方制剂等方面均为注册申报或中药监管所关注的热点或难点。重点比较了中国香港特别行政区中成药注册中固有药类别(古方)与中国内地经典名方(目前属于中药新药注册分类6.1类)注册申报的技术性资料要求的异同,同时对中药注射剂和中西药复方制剂不同的注册分类情况进行了对比。
英文摘要:
      The registration and application of new traditional Chinese medicine (TCM) involves a variety of situations, among which the TCM classical prescription, Chinese medicine injection, Chinese and western medicine compound preparation and other aspects are all the hot spots or difficulties in the registration and application or the supervision of TCM. This paper focuses on the comparison of the technical data requirements of the registration and application of the established medicines category (ancient prescription) in Hong Kong and the classic prescription in mainland of China (currently belonging to the new drug registration category 6.1 of TCM). At the same time, the registration classification of TCM injection and Chinese and western medicine compound preparation was compared.
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