Posted 17 October 2016
By Gretchen Dean, MA, Joel Hardink, MBA, MS
This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs.
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Categories: Drugs, Clinical, Submission and registration, News, China, CFDA, ICH
Tags: Electronic common technical document, eCTD, Clinical trial application, CTA,