Japan BE requirement [Regulatives / Guidelines]

posted by mangurohit – India, 2010-02-02 10:20 (5284 d 18:10 ago) – Posting: # 4692
Views: 4,698

Dear Friends,

Myself Mr. Mangu Rohit. I need your help to solve the query i have as below.

If we have to market our product in Japan, is it compulsory to do bioequivalence study in Japan only or we can do the bioequivalence study in other country (like India ) also and submit it to Japan regulatory are they accepting the data??

If Japan regulatory is not accepting the Bioequivalence study data performed in other countries then why it is not accepting??

and if accepting the data of bioequivalence study done in (few countries) which are these countries?

Thanks in advance

Regards

mangu

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