Current Drug Master File Status in Taiwan

Time

Wed, Jun 17 9:00AM
W 24

Title

Current Drug Master File Status in Taiwan

Abstract Summary

Information for DMF applications submitted and reviewed by CDE from October 2009 to December 2014 was retrieved from electronic data system in CDE. The results were analyzed in terms of the distribution of the manufacturing sites, approval rates, and deficiencies of dossiers, etc.

Poster Presenter

Shun-Lan Hsieh
CMC Reviewer,
Center for Drug Evaluation (CDE)
Taiwan