China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

Posted 23 April 2015 By Ji Wang, Jun Zuo, Hua Zhang, Thuy Dang and Joseph Scheeren, PharmD

A review of the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014, providing insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China.

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Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, Features, China

Tags: China, CFDA, China Food and Drug Administration, clinical trials, new drug approvals, new biologics approvals, Chinese patients, international multicenter trials, IMCT, Asia Pacific

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