欧盟GMP法规更新.pdf
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欧盟GMP法规更新
R
Dr Vee REVITHI
F. HOFFMANN – LA ROCHE Ltd
PTQG – External Relations Europe
April 2015
ISPE China Annual Spring Conference 2015 Beijing, China
概述
43 slides
• 历史: 欧盟法规历史
• 欧盟关于GMP和进口原料药的法规
• 欧洲药品管理局
• 近期欧盟GMP变更
2
欧盟多元化的28个成员国
2015年
The European flag The European anthem
Europe Day, 9 May The motto: United in diversity
3
28个成员国5亿8百万人口
CROATIA joined EU as the
28th M-S in 1 July 2013
Greece / ELLAS, my country,
where Princess Europe was
kidnapped by Zeus
transformed to a bull and
taken from Phoenice (now
Lebanon) to Crete
Member states of
the European Union
Candidate and
potential candidate
countries
4
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