Brazil's CROs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-02-02 15:03 (4577 d 22:24 ago) – Posting: # 4694
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Dear Mangu!

» 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??

According to Japanese Guidelines subjects must be of 'Japanese ethnic origin' (no exceptions). If you want to perform a study ouside of Japan, I would suggest to go to Sao Paulo. You will find there they largest Japanese community (0.5 Mio) outside of Japan. There are a couple of CROs approved by the ANVISA specialized in these kinds of studies.

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