China BE study [Regulatives / Guidelines]
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:
- Size of biobatch
A scaled-up batch or a full production batch.
- Body weight
Within the normal range according to accepted normal values for BMI. Should avoid high variability in subjects’ body weights.
Healthy male subjects recommended. Study population should be determined based on the specific situation for each drug product.
- BE limits
80.00–125.00% in general, except 70.00–142.86% for Cmax. If MR in steady state, evaluation of %PTF is a case-by-case decision.
Reference-scaling according to the FDA’s approach.
BE limits may need to be tightened based on clinical justification.
- Guidelines in Chinese only.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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