China BE study [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2019-09-04 15:15  – Posting: # 20540
Views: 900

Hi Ajit, Helmut

There is a possibility of submitting dossier without additional BE studies, if your product has been approved by US FDA/EMA/Japan, (and a few other countries that I forgot). There was a guideline with regard to acceptance of foreign BE but due to the change in the agency's website, I didn't have time to find it right now. Maybe later I can send you a link. That being said, however, Chinese FDA typically request much more data than EMA/US FDA (yes, I'm not kidding :-D), e.g., 100% subject profiles and 100% bioanalytical chromatograms instead of the typical 20%, .... So if you just submitted your old dossier, as Helmut said, the chance of success is almost 0.

In addition, there's a list of 48 drugs that are considered "urgently needed medicine" (notes in Chinese but the drug list in English). If your product is one of them, then the chance of acceptance without BE might be higher (with additional data requested by the agency of course).

All the best,
Shuanghe

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