Generic application cannot be submitted while the new drug is under re-examination period in Japan even if the patent of the new drug is expired.
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Toru Murakumo RAC
General Manager, Regulatory Affairs
LSI Medience Corporation
Tokyo
Japan
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Original Message:
Sent: 04-21-2014 04:46
From: Julia Lin
Subject: Generic submission in Japan
Does anyone know if generic application can be submitted while the new drug is under re-examination period in Japan?
Thanks for your help.
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Julia Lin
Global Regulatory Affairs Manager
Lotus Pharmaceutical Co., Ltd.
Nantou City
Taiwan
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