China Local BE study waiver [Regulatives / Guidelines]

posted by Ajit Thorat – India, 2019-08-29 07:26 (417 d 17:29 ago) – Posting: # 20528
Views: 2,429

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
21,162 posts in 4,410 threads, 1,476 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Tuesday 00:56 UTC (Europe/Vienna)

In theory, there is no difference between theory and practice.
But, in practice, there is.    Jan L.A. van de Snepscheut

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