CFDA and reference scaling [Regulatives / Guidelines]

posted by yicaoting  – NanKing, China, 2017-08-22 18:49 (2733 d 18:01 ago) – Posting: # 17731
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❝ To anyone's knowledge does the CFDA allow for FDA or EMA reference scaling? I tried looking into the current Chinese regulatory documents:


Hi BRB
I work in China. On this issue, from my experience with CFDA, they like to adopt US FDA's RSABE guidance.

We have submit such dossier using US FDA's method to CFDA.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

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