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China: What Lies Ahead in the Year of the Goat – 2015 Ling Su, PhD Strategic Advisor, Sidley Austin, LLC DIA Global Forum Regional Editor, China Fuyu Song, MS Peking University Clinical Research Institute “CFDA will improve drug review and approval efficiency through a streamlining process (especially the key steps), increasing headcounts and improving application fee management.” 54 Vol 7 Issue 2 Entering the Year of the Goat, 2015 will be important for the Chinese regulatory environment. Numerous regulations and guidelines adopted by the China Food and Drug Administration (CFDA) in 2014 will need to be implemented. At the same time, CFDA continues to work on the revision of the Drug Administration Law (DAL) and is expected to take steps and initiatives in regulatory reform. Measures to Speed up Drug Review and Approval CFDA has long been under the pressure from local and multinational pharmaceutical companies for its lengthy review and approval of pharmaceutical and biological products. The long timeline has resulted in significant drug lag and a large backlog of applications. “CFDA will improve drug review and approval efficiency through a streamlining process (especially the key steps), increasing