What Are The Non-Clinical Study Requirements For Drug Registration In Taiwan?

For drug registration in Taiwan, non-clinical study requirements include toxicology studies to assess potential risks, pharmacology studies to demonstrate biological activity, and pharmacokinetics to evaluate absorption, distribution, metabolism, and excretion. These studies ensure the drug’s safety before human trials. Compliance with international standards, such as ICH guidelines, is often required by the TFDA.

Leave a Reply

You must be logged in to post a comment.