Bioequivalence and Bioavailability Forum • Brazil's CROs

Brazil's CROs [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-02-02 16:03 (4801 d 04:08 ago) – Posting: # 4694
Views: 3,875

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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Japan BE requirement mangurohit 2010-02-02 09:20 [Regulatives / Guidelines]
- Brazil's CROsHelmut 2010-02-02 15:03
  - Bioequivalence in Japan mangurohit 2010-02-03 05:21
    - Bioequivalence in Japan Helmut 2010-02-03 11:10
  - Japanese Guideline of Bioequivalence Brus 2021-02-24 16:30
    - Japanese Guideline of Bioequivalence Helmut 2021-02-24 18:07
      - Japanese Guideline of Bioequivalence Brus 2021-02-25 11:46