通用名/商品名流程
2025-07-10 10:34:41 0 举报药品注册-通用名商品名流程
作者其他创作
大纲/内容
USAN Council issues Statement of Adoption
WHO & USAN INN
~4 Months
受理
Publication in recommended INN list
In NDA/BLA 90 days
30个工作日
~9个月
INN Committee meets
中国 BLA
submits accepted name to USAN
药品上市许可申请
NDA/BLA
Include INN in the USP Dictionary of USAN and International Drug Names
Brand Name Regulatory Submission Timing
3~4 Months
In IND 180 days
As early as 18 months prior to Marketing Authorization Application (MAA)Submission
Review by USAN Council
Publication in proposed INN list
Strategy
商品名申请
1-4周 商标注册受理单
通用名核准申请
TradeMark
Part of NDA submission package
END of PHASE II of IND
商标注册证
~1~2 Months
~12个月
批准
Application submitted to INN
~10 Months
CDE
药典委
~3个月
商标注册申请
WIPO
~4~5 Months
4 Months Objection period
Athority
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