Importing EU sourced generic co-medication into S-Korea and Taiwan

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March 24, 2026

Importing EU sourced generic co-medication into S-Korea and Taiwan

How to regulatory file an onco-generic sourced from EU (or US) when a representative SmPCs is not allowed, and you do not know from which manufacturer you source (due to market availability? Is it better to source locally?

For Taiwan specifically is there a need to comply with the requirement of a CoA during submission, even for sourced IMP for which a CoA may not be provided, or for which a CoA is not available yet?

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