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A Pilot Plan of E Platform for Review & Submission (E-PRESS) 【Date:2017-11-16】 unit:藥品組

Taiwan Food and Drug Administration (TFDA) announced a pilot plan of E Platform for Review and Submission (called E-PRESS) on October 23, 2017, which as we all know the e-submission.

In general, the e-submission is not only to focus on the minimization of paper use during the exchange of information between applicants and authorities, but also to enhance the quality and efficiency of the medicinal product registration process, shorten innovated product review time.

TFDA has established an electronic platform for review and submission. In this pilot plan, it is also to provide priority review as an incentive for license holders to increase the E-PRESS utilization. Furthermore, TFDA will continue to evaluate the effectiveness of E-PRESS and revise it if necessary.

The portal page of E-PRESS, operating manual and relevant Q&A can be found on the following link :( http://e-sub.fda.gov.tw/dohclient/Manager/Login.aspx)