Ajit Thorat

2019-08-29 11:26
(1695 d 00:28 ago)

Posting: # 20528
Views: 4,053

 China 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.
Vienna, Austria,
2019-08-29 12:34
(1694 d 23:20 ago)

@ Ajit Thorat
Posting: # 20529
Views: 3,642

 China BE study

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 Cmax. 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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Helmut Schütz

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2019-09-04 17:15
(1688 d 18:39 ago)

@ Helmut
Posting: # 20540
Views: 3,446

 China BE study

Hi Ajit, Helmut

There is a possibility of submitting dossier without additional BE studies, if your product has been approved by US FDA/EMA/Japan, (and a few other countries that I forgot). There was a guideline with regard to acceptance of foreign BE but due to the change in the agency's website, I didn't have time to find it right now. Maybe later I can send you a link. That being said, however, Chinese FDA typically request much more data than EMA/US FDA (yes, I'm not kidding :-D), e.g., 100% subject profiles and 100% bioanalytical chromatograms instead of the typical 20%, .... So if you just submitted your old dossier, as Helmut said, the chance of success is almost 0.

In addition, there's a list of 48 drugs that are considered "urgently needed medicine" (notes in Chinese but the drug list in English). If your product is one of them, then the chance of acceptance without BE might be higher (with additional data requested by the agency of course).

All the best,
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