天道酬勤--药品注册质量管理

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天道酬勤

擅长药品注册,有多个项目的美国DMF, EDQM CEP, PMDA MF, 国内IND和仿制药成功申报经验

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药政网站/网址

2009-03-26 16:17:22| 分类：默认分类 | 标签： |举报 |字号大中小订阅

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网站名称/网址
网站名称/网址
Food and Drug Administration (FDA)
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/cder/guidance/index.htm#newly_added
http://www.fda.gov/cder/dmf/
http://www.emea.europa.eu/
http://www.emea.europa.eu/htms/human/humanguidelines/quality.htm
http://www.emea.europa.eu/htms/human/raguidelines/post.htm
http://www.emea.europa.eu/htms/human/genguidance/regaffairgen.htm
http://www.edqm.eu/site/Whats_new-525.html
http://www.edqm.eu/site/News_and_General_Information-43.html http://www.edqm.eu/site/News_amp_General_Information-164.html
http://www.edqm.eu/site/The_European_Pharmacopoeia_6th_Edition-681.html
http://www.edqm.eu/site/EDQM_Reference_Standards-649.html
http://www.edqm.eu/site/Certificates_of_Suitability-97.html
Pharmaceutical Inspection Cooperation Scheme（PIC）
http://www.picscheme.org/
http://www.picscheme.org/news.php http://www.picscheme.org/publication.php?p=guides
The State Food and Drug Administration (SFDA)
http://www.cde.org.cn/news.do?method=news_index
http://www.cde.org.cn/zdyz.do?method=initValue&frameStr=0
http://www.cde.org.cn/policy.do?method=policy_index
http://www.ich.org/cache/compo/276-254-1.html
http://estri.ich.org/eCTD/index.htm http://www.pda.org/
http://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs.aspx
The United States pharmacopeia (USP)
http://www.usp.org/
http://www.usp.org/referenceStandards/
http://www.usp.org/USPNF/
http://www.usp.org/USPVerified/pharmaceuticalIngredients/
Active Pharmaceutical Ingredients Committee (APIC)
http://apic.cefic.org/publications/publications.html
http://apic.cefic.org/position/position.html
http://apic.cefic.org/hot_topics/hot_topics.html

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天道酬勤--药品注册质量管理

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