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RegisterChina Local BE study waiver [Regulatives / Guidelines]
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.
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:
- China Local BE study waiverAjit Thorat 2019-08-29 09:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- China BE study Helmut 2019-08-29 10:34
- China BE study Shuanghe 2019-09-04 15:15
- China BE study Helmut 2019-08-29 10:34
Ing. Helmut Schütz