文章摘要
杜瑶,陈在余,王敏.香港澳门药品注册管理的比较研究[J].中国药事,2018,32(9):1181-1187
香港澳门药品注册管理的比较研究
Comparative Study on Drug Registration Management in Hong Kong and Macao
投稿时间:2018-03-14  
DOI:10.16153/j.1002-7777.2018.09.005
中文关键词: 香港  澳门  药品注册  中药注册  注册要求  注册程序
英文关键词: Hong Kong  Macao  drug registration  traditional Chinese medicine registration  registration requirement  registration procedure
基金项目:
作者单位E-mail
杜瑶 中国药科大学商学院, 南京 211198  
陈在余 中国药科大学商学院, 南京 211198  
王敏 国家食品药品监督管理总局药品审评中心, 北京 100022 wangm@cde.org.cn 
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中文摘要:
      目的:将香港澳门的药品注册管理进行系统的比较研究,为内地药品到港澳上市提供参考。方法:运用文献研究和政策分析法,对港澳地区的药品注册管理体系、药品注册要求以及注册申报程序进行对比分析。结果:港澳的药品注册管理机制不同,香港的药品管理法律体系呈平行管理的特点,对中西药独立监管注册,中药实行中成药注册分类制度,并根据注册组别不同提交不同资料;而澳门的药品法律体系尚未统一,对药品集中注册管理,实行预先登记机制,中药实行中药预先许可制度。结论:内地药品在港澳注册上市,有利于提高内地企业的国际化和药物研发水平;内地企业在港澳申请注册时,应熟悉港澳药品注册管理政策,并与当地经销商合作,积极开展国际多中心临床试验;而提高内地企业药品研发质量,促进三地临床数据互认,有利于实现三地互利共赢的目标。
英文摘要:
      Objective: To systematically compare the drug registration management in Hong Kong and Macao and to provide references for selling mainland drugs in the market of Hong Kong and Macao.Methods: By means of literature research and policy analysis, a comparative analysis of drug registration management system, drug registration requirements and registration application procedures in Hong Kong and Macao was carried out.Results: Drug registration management mechanisms in Hong Kong and Macao are different. The legal system of drug administration in Hong Kong is characterized by parallel management. Chinese and Western medicines are regulated and registered independently. The registration and classification system of traditional Chinese medicines is implemented, and different materials are submitted according to different registration groups. However, the pharmaceutical legal system in Macao has not yet been unified. The centralized management of drugs is managed, the pre-registration mechanism and the pre-licensing system for traditional Chinese medicines are implemented.Conclusion: The registration and selling of mainland medicines in Hong Kong and Macao are conducive to the promotion of the internationalization of mainland enterprises and the level of drug research and development. Mainland enterprises should be familiar with the drug registration management policies, cooperate with local distributors and actively carry out international multi-center clinical trials when applying for registration in Hong Kong and Macao in order to improve the quality of pharmaceutical research and development in mainland enterprises, so as to the mutual recognition of clinical data in the three places, help to realize the win-win goal among the three places.
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