I suppose you already know but the Japanese only database for medicine is as follows:
https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.htmlIf you want the package insert for the medical devices, the web site is here:
https://www.info.pmda.go.jp/ysearch/html/menu_tenpu_base.htmlhowever, not like medicine, they don't provide the package insert for all the products.
(It is not mandatory to register all the package insert yet. I heard it will become mandatory within a few years, then, you can see the documents for all the products.)
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Soichiro Iida
Kyoto-Shi
Japan
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Original Message:
Sent: 05-Aug-2020 08:19
From: Beth Weinberg
Subject: Japanese Package insert
thank you!
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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
Original Message:
Sent: 04-Aug-2020 11:28
From: Breanne Cuddington
Subject: Japanese Package insert
Hello Beth,
Are you referring to the Tempubunsho? My understanding is that this document is created by your DMAH and depends on the information provided in the product approval submission and also contains approval information. An english copy can be requested from the DMAH but they generally do not provide one to the foreign manufacturer by default.
Hope that helps.
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Breanne Cuddington
Regulatory Affairs Lead
Kitchener ON
Canada
Original Message:
Sent: 02-Aug-2020 17:24
From: Beth Weinberg
Subject: Japanese Package insert
I have looked and looked, but don't seem to be able to find an English version of a Japanese Package Insert. Can anyone direct me?
thank you!
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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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