What Are The Bioequivalence Requirements For Generics In Taiwan?

In Taiwan, bioequivalence studies are required for generic drugs to demonstrate that they have the same bioavailability as the reference product. These studies compare the absorption rate and concentration of the active ingredient in the bloodstream. The TFDA mandates strict compliance with Good Clinical Practice (GCP) to ensure accurate results and regulatory approval.

Leave a Reply

You must be logged in to post a comment.