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  • Feature ArticlesFeature Articles

    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...
  • Topic of Regulation Central to APEC Meeting

    Regulators from Asia-Pacific Economic Cooperation (APEC) member countries discussed the topic of regulation and its effect on member economies during a recent meeting in Russia, according to press releases from the meeting. The trade liberalization forum of 21 nations met in Moscow in February to discuss ways to increase market access to the Asia-Pacific region by 25% in the next four years. The organization particularly focuses on the movement of physical goods, which i...
  • APEC Affirms Role and Importance of Regulatory Reform in 2012

    The Asia-Pacific Economic Cooperation (APEC) forum recently affirmed that "advancing regulatory cooperation and convergence" is a priority for the organization in the new year. In the 3 January, 2012 posting , APEC staff frequently reference their November, 2011 " Honolulu Declaration ", which calls for increased economic integration, regulatory reform, and regulatory cooperation . Specifically, APEC hopes to strengthen food safety systems and facilitate trade, prevent...