Dear Ivan,
Recently enacted changes to pharmaceutical law in Japan provide
significant opportunities for non- Japanese companies to increase
their market presence in the country and provide manufacturing
services to its pharmaceutical industry.
Any factory manufacturing drugs (drug products) for sale in Japan,
wherever it's located, must have a Japanese pharmaceutical
manufacturing business license and comply with Japanese cGMP
requirements. The MHLW certifies overseas plants that supply drugs to
Japan, and it is ministry policy to inspect such plants before that
certification. As a signatory to ICH, Japan is working with EMEA and
FDA committees to harmonize regulations, but this work is not yet
complete.
For your reference, please refer the following, which might help you
for your query-
1. Pharmaceutical Manufacturing Handbook: Regulations and Quality, By
Shayne Cox Gad Page no-125, Its available on Google. This page gives
information about drug manufacturer who plans to sale his product in
japan.
2. Pharmaceutical Administration and Regulations in Japan. (March 2008)
This guide contains information concerning pharmaceutical
administration, regulations, and new drug development in Japan. You
can refer chapter 2.
please find the attachment.
Hope this helps to get you the right solution or your query.
Thanks
Surender
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