Can I read US and EU Generic Drug Submission Guide on EtoBox?

US and EU Generic Drug Submission Guide by vg_vvg is a document available to read on EtoBox.

What is US and EU Generic Drug Submission Guide about?

This document provides a comparative study of the requirements for submitting generic drug applications in CTD/eCTD format across the US and EU. It discusses how the ICH harmonized technical requirements for drug applications in the CTD format to increase efficiency. While some modules are common to both regions, there are still differences in requirements within common modules according to each region

Author

vg_vvg

Language

EN