biowaiver requirement for APAC (Asia Pacific) [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-12-18 04:45 (282 d 14:05 ago) – Posting: # 20989
Views: 1,005

Hi,

Does anyone know of the biowaiver requirements for APAC (Asia pacific) submission? Specifically, a biowaiver for oral solution (a site change waiver). Is it similar to the requirements for USA and EMA (I think so right but would like to get your feedback).

thx
J

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