China BE study [Regulatives / Guidelines]
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:
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.
- Guidelines in Chinese only.
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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- China Local BE study waiver Ajit Thorat 2019-08-29 09:26 [Regulatives / Guidelines]
- China BE studyHelmut 2019-08-29 10:34
- China BE study Shuanghe 2019-09-04 15:15
- China BE studyHelmut 2019-08-29 10:34