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

This topic has 0 replies, 1 voice, and was last updated 2 months, 2 weeks ago by Anonymous.

Viewing 1 post (of 1 total)

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?

Viewing 1 post (of 1 total)

You must be logged in to reply to this topic.

Become a member

Join GCSG for full access...

to our educational resources, conference materials and our directory of more than 480 Clinical Supply colleagues. Experience the culture of collaboration, It only takes approximately 3 minutes 22 seconds.

Please note that membership is included and FREE of charge when you sign up for an event.

Join Renew