Discussion Between Two Centers First Ever to Take Place in U.S.
Senior drug regulatory officials from mainland China and Taiwan will be in Boston on June 25 to discuss—for the first time in the U.S.—the need for more collaboration between the two agencies in getting drugs through the regulatory process in a timely manner. Representatives from the Taiwan and mainland China centers of drug evaluation will share respective best practices and processes in drug review during the Convergence in Regulatory Science Across the Strait panel at the DIA 2013 49th Annual Meeting.
While mainland China’s pharmaceutical market has experienced significant growth in recent years, fueled by an infusion of government funding in health care, regulatory processes have not yet adapted to demand. Review time and capability differences can slow down product registration.
The panel discussion is scheduled for 1:45 p.m. on June 25 at the Boston Convention & Exhibition Center. Topic areas will include investigational new drug review and good review practice and may also explore further opportunities for joint efforts in promoting drug development, especially the specific therapeutic areas of unmet medical needs in mainland China.
“This session will form the basis for a unique discussion of collaboration opportunities and areas of convergence in regulatory science between mainland China and Taiwan,” said DIA Board President Ling Su, Ph.D. “DIA’s international reputation to provide a neutral, global forum allows for this discussion on issues facing these two centers in regulation processes.”
Representing the panel from mainland China’s Center for Drug Evaluation are Yi Feng, director of the Office of Evaluation Management and Communication, and Zhen Chen, Ph.D., deputy office director of the Office of New Drug Pharmaceutical Science. The Taiwan Center for Drug Evaluation will be represented by reviewers Hsin-Jung Lee and Mey Wang, Ph.D. The session will be chaired by Dr. Ning Li, M.D., Ph.D., vice president of regulatory and medical policy in the Asia region for Sanofi China.
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