GMP新闻

https://www.gmp-compliance.org/gmp-news/latest-gmp-news

https://www.gmp-publishing.com/en/gmp-news.html

FDA CDER指南

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

FDA警告信

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2018/default.htm

USP http://www.uspnf.com/official-text/proposal-statuscommentary?_ga=2.182866790.1798957854.1528958376-508059452.1528188700(b3ntuzitgyzk/yurt3dais)

EU GMP指南

https://ec.europa.eu/health/documents/eudralex/vol-4_en

Major developments

https://ec.europa.eu/health/human-use/good_manufacturing_distribution_practices/gmp_developements_en

EU GMP检查不符合报告

http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do

EMA GMP问答

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000027.jsp

EMA 科学指南

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp

EMA 新消息？

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp

EDQM 

EP 9 http://www.edqm.eu/en/european-pharmacopoeia-ph-eur-9th-edition  online.edqm.eu(ArXD909q0hfy/archives90,ArXD91xbxgrg/archives91,ArXD92qir1qv/archives92)

QM Documents http://www.edqm.eu/en/quality-management-guidelines-86.html

APIC http://www.apic.cefic.org/publications.html

WHO

GMP http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

GDP http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/

TRS to Prequalification

http://extranet.who.int/prequal/content/who-technical-report-series

New texts under review (Working documents/QAS)

http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/

ICH  http://www.ich.org/ichnews/newsroom/

CFDA

公告通告 http://cnda.cfda.gov.cn/WS04/CL2050/

法规文件 http://cnda.cfda.gov.cn/WS04/CL2051/

其他公告 http://samr.cfda.gov.cn/WS01/CL0087/

http://www.cde.org.cn/policy.do?method=policy_index

http://www.chp.org.cn/

翻译：

http://weixin.sogou.com/　(FDA警告信、ECA新闻)

https://translate.google.cn/

https://cn.bing.com/translator/

http://fanyi.baidu.com/#en/zh/

GAMP = Generally Anticipated Mountains of Paper