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

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
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    Opportunities and Challenges of Global Drug Development in Asia: Are you ready?

    Global drug development needs Asia, and Asia needs global drug development. Regulatory professionals working on global development programs should know how to maximize the benefits and minimize the risks associated with including Asia in global programs. For Asia, global drug development presents many opportunities, including the potential to enhance patient outcomes, engage local researchers in international clinical trials, encourage mutually beneficial interactions be...