Bioequivalence and Bioavailability Forum • CFDA and reference scaling

CFDA and reference scaling [Regulatives / Guidelines]

posted by yicaoting – NanKing, China, 2017-08-22 18:49 (2432 d 02:27 ago) – Posting: # 17731
Views: 15,267

❝ 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]

Complete thread:

CFDA and reference scaling BRB 2017-07-20 15:44
- CFDA and reference scaling Helmut 2017-07-20 22:09
  - CFDA and reference scaling BRB 2017-07-20 22:33
    - CFDA and reference scaling Shuanghe 2017-07-21 18:09
      - OT: Uplading / attaching files Helmut 2017-07-21 18:25
    - CFDA: seemingly like the EMA Helmut 2017-07-21 19:23
      - CFDA: seemingly like the EMA Shuanghe 2017-07-24 18:47
- CFDA and reference scalingyicaoting 2017-08-22 16:49
  - CFDA and reference scaling Helmut 2017-08-22 16:59
    - CFDA and reference scaling Shuanghe 2017-08-29 13:12
      - CFDA and reference scaling yicaoting 2017-08-29 18:51