CFDA and reference scaling [Regulatives / Guidelines]

posted by yicaoting  – NanKing, China, 2017-08-29 20:51 (2402 d 18:00 ago) – Posting: # 17752
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❝ 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)


Hi Shuanghe
Yes, our submission is under review now. But we believe that CFDA will like to accept FDA's method. The drug product is listed on FDA's Drug Product Specific BE Recommendation List. As far as we know, (I am working in a big Pharma in China) CFDA is putting more and more emphasis on learning the list. The reviewer usually gives us suggestion and requirement according to FDA's BE recommendations, especially those drugs are clearly listed and those with more special properties such as HVDs and NTIDs. As you know, a lot of reviewers (such as He Ruyi serves as CSO for CFDA now) come back to CFDA from FDA these years, this definitely will has some influence on the CFDA's attitude to many issues in drug application review.
BTW, are you working in China now?

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