Brazil's CROs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-02-02 15:03 (4373 d 12:46 ago) – Posting: # 4694
Views: 3,588

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 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,844 posts in 4,571 threads, 1,555 registered users;
online 19 (0 registered, 19 guests [including 7 identified bots]).
Forum time: Monday 03:49 CET (Europe/Vienna)

Do, or do not.
There is no ‘try’.    Yoda

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5