China Local BE study waiver [Regulatives / Guidelines]

posted by Ajit Thorat – India, 2019-08-29 11:26 (2142 d 01:18 ago) – Posting: # 20528
Views: 5,245

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
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,684 registered users;
40 visitors (0 registered, 40 guests [including 10 identified bots]).
Forum time: 12:45 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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