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Hi Helmut,
As I mentioned in previous post, initially it seems that CFDA adopted EMA's method by their guideline in 2015 as an appendix of the Chinese Pharmacopeia; however, the newer guideline was published in 2016 and it's basically a copy of FDA's guidance. That's one of the reasons I said that "FDA beats EMA in China". The confusion/uncertainty comes from the fact that, unfortunately, RSABE was only mentioned in 2015 guideline but not in 2016 guideline. Though it's not clear from guideline perspective, in practice, I had a feeling that Zhang Yong might be right about CFDA's preference of FDA method though no one can be sure unless they submitted such method and the dossier was approved.
Hi Zhang Yong,
From the context I understood that you only submitted dossier to CFDA. What's their opinion? The dossier is approved or are you still waiting for the possible "deficient letter" (or whatever name they call it in china)?
For BRB, I think that if you really want to be sure that the correct method is used, it might be worthwhile to contact CFDA.
❝ That’s interesting given Shuanghe’s post above and followings – which point towards the EMA’s method. Strange.
As I mentioned in previous post, initially it seems that CFDA adopted EMA's method by their guideline in 2015 as an appendix of the Chinese Pharmacopeia; however, the newer guideline was published in 2016 and it's basically a copy of FDA's guidance. That's one of the reasons I said that "FDA beats EMA in China". The confusion/uncertainty comes from the fact that, unfortunately, RSABE was only mentioned in 2015 guideline but not in 2016 guideline. Though it's not clear from guideline perspective, in practice, I had a feeling that Zhang Yong might be right about CFDA's preference of FDA method though no one can be sure unless they submitted such method and the dossier was approved.
Hi Zhang Yong,
From the context I understood that you only submitted dossier to CFDA. What's their opinion? The dossier is approved or are you still waiting for the possible "deficient letter" (or whatever name they call it in china)?
For BRB, I think that if you really want to be sure that the correct method is used, it might be worthwhile to contact CFDA.
—
All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- CFDA and reference scaling BRB 2017-07-20 15:44 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 scaling Shuanghe 2017-07-21 18:09
- CFDA and reference scaling BRB 2017-07-20 22:33
- CFDA and reference scaling yicaoting 2017-08-22 16:49
- CFDA and reference scaling Helmut 2017-08-22 16:59
- CFDA and reference scalingShuanghe 2017-08-29 13:12
- CFDA and reference scaling yicaoting 2017-08-29 18:51
- CFDA and reference scalingShuanghe 2017-08-29 13:12
- CFDA and reference scaling Helmut 2017-08-22 16:59
- CFDA and reference scaling Helmut 2017-07-20 22:09
Ing. Helmut Schütz