China Local BE study waiver [Regulatives / Guidelines]

posted by Ajit Thorat – India, 2019-08-29 09:26  – Posting: # 20528
Views: 1,325

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:

Activity
 Admin contact
20,236 posts in 4,258 threads, 1,396 registered users;
online 8 (0 registered, 8 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 15:08 CET

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

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