i*****c
发帖数: 1322 | 1 【 以下文字转载自 RegulatoryAffairs 讨论区 】
发信人: iminusc (布衣王二), 信区: RegulatoryAffairs
标 题: 问一个中国药品在美国注册的问题
发信站: BBS 未名空间站 (Tue Sep 22 12:40:49 2015, 美东)
一个药的片剂想在美国上市，临床3期已经做完了（在中国），请问在美国能申请NDA吗
？需要申请IND吗？如需要，还要做1期2期吗？这个药的注射剂已经在中国上市10年了
。多谢了。 | a*********7
发帖数: 180 | 2 请问是New Molecular Entity么?还是new dosage form?？
Based on your limited info, if the obtained clinical data are sufficient to
support the Efficacy and Safety,as justified by the clinical reviewer at FDA
, then no need to file CTAs as IND for Phase I/II. But it sounds like the
data may not be representative to the US demographic info.
However, I really need more information in order to make a conclusion.
p.s. I am a CMC reviewer for pre-market authorization & CTA, not at FDA. 可
以PM. | i*****c
发帖数: 1322 | 3 【 以下文字转载自 RegulatoryAffairs 讨论区 】
发信人: iminusc (布衣王二), 信区: RegulatoryAffairs
标 题: 问一个中国药品在美国注册的问题
发信站: BBS 未名空间站 (Tue Sep 22 12:40:49 2015, 美东)
一个药的片剂想在美国上市，临床3期已经做完了（在中国），请问在美国能申请NDA吗
？需要申请IND吗？如需要，还要做1期2期吗？这个药的注射剂已经在中国上市10年了
。多谢了。 | a*********7
发帖数: 180 | 4 请问是New Molecular Entity么?还是new dosage form?？
Based on your limited info, if the obtained clinical data are sufficient to
support the Efficacy and Safety,as justified by the clinical reviewer at FDA
, then no need to file CTAs as IND for Phase I/II. But it sounds like the
data may not be representative to the US demographic info.
However, I really need more information in order to make a conclusion.
p.s. I am a CMC reviewer for pre-market authorization & CTA, not at FDA. 可
以PM. | f*****y
发帖数: 709 | | f*****y
发帖数: 709 | | f*****y
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