医药生物技术专栏 |
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我国生物制品通用名命名原则的修订 |
郭中平, 徐莉 |
国家药典委员会 北京 100061 |
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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 |
[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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