China BE study [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-08-29 10:34  – Posting: # 20529
Views: 1,053

Hi Ajit,

please follow the Forum’s Policy.

» Can we submit USFDA approved ANDA dossier to CFDA for drug Registration

You can submit everything but the chance for acceptance is close to nil.

» […] we need to do Fresh BE study in chinese population

Correct. Like most jurisdictions the National Medical Products Administration, Center for Drug Evaluation (NMPA, CDE) – formerly the China Food and Drug Administration or CFDA – requires the local reference product in the study.* Only if the innovator’s product is not approved in China, one can use the major market’s corresponding product.

There are some more differences to the FDA’s requirements to observe:


Cheers,
Helmut Schütz
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