China Local BE study waiver [Regulatives / Guidelines]

posted by Ajit Thorat – India, 2019-08-29 09:26 (1077 d 07:53 ago) – Posting: # 20528
Views: 3,657

1. Can we submit USFDA approved ANDA dossier to CFDA for drug Registration
2. In this case can we take waiver for BE study or we need to do Fresh BE study in chinese population

Please Guide for the same.

Complete thread:

UA Flag
 Admin contact
22,292 posts in 4,666 threads, 1,584 registered users;
online 9 (2 registered, 7 guests [including 2 identified bots]).
Forum time: Wednesday 17:20 CEST (Europe/Vienna)

There ain’t no rules around here!
We’re trying to accomplish something!    Thomas Alva Edison

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