China Local BE study waiver [Regulatives / Guidelines]

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

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