Dr_Dan
★★  

2020-05-25 13:22
(557 d 04:38 ago)

Posting: # 21462
Views: 1,296
 

 link to Chinese BE-Guideline [Regulatives / Guidelines]

Dear Forum Members
Could anybody provide the correct link to the Chinese BE-Guideline? http://www.sfda.gov.cn/directory/web/WS01/images/MjAxNsTqtdo2MbrFzai45ri9vP4zLmRvY3g=.docx
as mentioned under BEBAC/Guidelines/China gives an error message.:-(
Thank you very much for your help.

Kind regards and have a nice day
Dr_Dan
Shuanghe
★★  

Spain,
2020-05-25 22:16
(556 d 19:43 ago)

@ Dr_Dan
Posting: # 21466
Views: 877
 

 link to Chinese BE-Guideline

Dear Dan,

» Could anybody provide the correct link to the Chinese BE-Guideline? http://www.sfda.gov.cn/directory/web/WS01/images/MjAxNsTqtdo2MbrFzai45ri9vP4zLmRvY3g=.docx
» as mentioned under BEBAC/Guidelines/China gives an error message.:-(

They changed the website. You can find all guidance at this link.

Specifically, Guidance for PK-based BE, for HVDP, and for statistics.

The general link above contains much more (for chemical compounds) in case you are interested. For others such as biological products, follow the link in the left panel on that pages.

All the best,
Shuanghe
Dr_Dan
★★  

2020-05-26 11:49
(556 d 06:10 ago)

@ Shuanghe
Posting: # 21467
Views: 816
 

 link to Chinese BE-Guideline

Dear Shunghe
Thank you so much. Your help is very much appreciated.

Kind regards and have a nice day
Dr_Dan
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