link to Chinese BE-Guideline [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2020-05-25 22:16 (328 d 20:18 ago) – Posting: # 21466
Views: 732

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

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