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RegisterJapan BE requirement [Regulatives / Guidelines]
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
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
Complete thread:
- Japan BE requirementmangurohit 2010-02-02 09:20
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Brazil's CROs Helmut 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
- Japanese Guideline of Bioequivalence Helmut 2021-02-24 18:07
- Bioequivalence in Japan mangurohit 2010-02-03 05:21
- Brazil's CROs Helmut 2010-02-02 15:03
Ing. Helmut Schütz