August 10, 2018 PR-M08-18-NI-123
(BEIJING) In another positive development in China's rapidly evolving regulatory environment The China National Drug Administration (CNDA) has introduced a 60-day window for clinical trial approvals, mirroring US FDA protocols. The rules have taken immediate effect.
"This new ruling has major implications for sponsors wishing to conduct China-only or multi-centre studies which include China," said Philip Gregory, George Clinical China's Managing Director. "These changes should make China an even more attractive destination for cost-efficient studies, given the high numbers of prospective patients."
According to a recent translation of the guidelines:
"It's very encouraging to see the CNDA place such importance on the streamlining of China's approval process," Mr Gregory continued. "It shows a steady, ongoing commitment by the Central Government to make China a leading clinical trial destination."
For more information, contact:
Philip Gregory
Managing Director China
https://www.georgeclinical.com
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