Event Information

Time: January 19, 2017 (Thursday)

Place: TRPMA Conference Room

TRPMA invited Dr Churn-Shiouh Gau, the Executive Director of the Center for Drug Evaluation (CDE), to introduce the CDE’s latest drug advisory mechanism. This mechanism provides guidance on general regulations, criteria for index cases, rolling review, pre-NDA meeting, pre-ANDA meeting and issues concerning drug review.

Dr Gau also mentioned the CDE’s short-term and medium-term plans. The CDE aims to provide assistance for drug manufacturers in Taiwan at various R&D stages through organizing “milestone meetings” at Pre-IND, End of Phase I, End of Phase II and Pre-NDA stages.

TRPMA members raised questions and put forward suggestions to Dr Gau in the follow-up Q&A session with a view to strengthening the collaboration between the CDE and the industry so as to push the industry forward.