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Revision of the General Policies of Nomenclature for Biological Products in China |
GUO Zhong-ping, XU Li |
Biologics Division, Chinese Pharmacopoeia Commission, Beijing 100061, China |
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Abstract General Policies of Nomenclature for Biological Products in China were studied, aimed at establishing and perfecting the system of Chinese approved biologic name. By means of analysis of the current situation and existing problems of nomenclature for biological products and the development trend of new biotherapeutics. It is sufficiently studied on the existing leading international drug generic naming system,and the specific suggestions on revision of the General Policies of Nomenclature for Biological Products in China based on the naming principles of WHO INN and Chinese language recognition were put forward.
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Received: 07 February 2017
Published: 25 August 2017
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[1]国家食品药品监督管理局.中华人民共和国药品管理法.[2015-04-24].http://www.sda.gov.cn/WS01/CL0784/124980.html.Chinese Food and Drug Administration.Drug Administration Law of the People's Republic of China.[2015-04-24].http://www.sda.gov.cn/WS01/CL0784/124980.html. [2]中国生物制品标准化委员会.中国生物制品规程.北京:化学工业出版社,2000.3-5.Chinese Committee on the Standardization of Biological Products.Chinese Pharmacopoeia 2000 Edition.Beijing:Chemical Industry Press,2000.3-5. [3]国家药典委员会.中国药典(三部).北京:中国医药科技出版社,2015.ⅩⅣ.Chinese Pharmacopoeia Commission.Chinese Pharmacopoeia (Volume Ⅲ).Beijing:China Medical Science Press,2015.ⅩⅣ. [4]国家药典委员会.中国药品通用名称.北京:化学工业出版社,2014.Chinese Pharmacopoeia Commission.Chinese Approved Drug Name.Beijing:Chemical Industry Press,2014. [5]郭中平.生物药通用名命名的探讨.中国新药杂志,2014,23(20):2394-2398.Guo Z P.Discussion on the naming of biological products.Chinese Journal of New Drugs,2014,23(20):2394-2398. [6]World Health Organization.International Nonproprietary Names (INN) for biological and biotechnological substances (a review).[2016-2-20].http://www.who.int/medicines/services/inn/BioReview2016.pdf?ua=1. [7]国家食品药品监督管理局.生物类似药研发与评价技术指导原则.[2015-02-28].http://www.sda.gov.cn/WS01/CL1616/115104.html.Chinese Food and Drug Administration.Guideline for the development and evaluation of biological similar drugs.[2015-02-28].http://www.sda.gov.cn/WS01/CL1616/115104.html. [8]World Health Organization.WHO_INN_BQ_proposal_2015.[2015-10-31].http://www.who.int/medicines/services/inn/WHO_INN_BQ_proposal_2015.pdf?ua=1. [9]Robertson J S.The challenges of nomenclature-INN,biosimilars and biological qualifiers.Generics and Biosimilars Initiative Journal,2015,4(3):110-112. [10]U.S.Food and Drug Administration.Nonproprietary Naming of Biological Products Guidance for Industry.[2017-1-31].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm459987.pdf. |
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