China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications

Posted 17 October 2016 By Gretchen Dean, MA, Joel Hardink, MBA, MS

placeholder+image 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,

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