Bioequivalence and Bioavailability Forum

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:

• 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.
  
• Sex
  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 C_max. If MR in steady state, evaluation of %PTF is a case-by-case decision.
  • HVD(P)s
    Reference-scaling according to the FDA’s approach.
    
  • NTIDs
    BE limits may need to be tightened based on clinical justification.

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• Guidelines in Chinese only.