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Hello,
Does anyone have any information regarding the current requirements for a US based API manufacturer to export an API into China? It is my understanding that the CFDA did away with the IDL process in late 2016, and I have not been able to find any information regarding the current requirements for a foreign manufacturer to obtain CFDA approval to export an API into China. Much of the information available online regarding the CFDA and foreign manufacturers is old and now outdated.
Will the CFDA accept a US FDA issued API CPP, or is a translated technical dossier prepared/submitted via an in-country agent required for an API?
In regard to an excipient product (unlike the US FDA, which will allow companies to submit/register a DMF even if no one is referencing it), from what I understand, the CFDA will only accept an excipient dossier if the associated material is tied in with a CFDA finished product application (IND, NDA, etc.). Is it the same CFDA process/expectation for APIs?
If someone is able to shed some light on the CFDA and foreign manufacturers in regard to APIs, that would be appreciated.
Thank you very much.