Replies to post #118049 on Biotech Values

[ghmm]

Thanks,I figured as such. I was only aware of Japan requiring such studies but perhaps its more common than I thought.

[genisi]

Approval of the “import” route also known as a Class 3, requires a PK/PD study to prove bioequivalence and a single phase III confirmatory trial, both in Chinese patients. The problem usually isn't the trials but the inefficiencies of the SFDA with relatively long review process and then not many clinical sites. It's improving though.