(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:

  • Applicants must apply for a communication meeting with the CDE before filing an Investigational New Drug (IND) dossier as per relevant requirements.
  • The CDE will complete the formal examination within 5 days of filing, and issue a formal notice of acceptance unless corrections are required. Then, if no further questions arise from the CDE within 60 days of fee payment, clinical trials can be initiated as per the submitted clinical trial protocol.
  • Where a filing falls short of technical review requirements, the CDE will inform applicants of all needed corrections in one communication, and applicants will have five days to supplement information or make other amendments as required. Another 60-day window would open once such corrected filings have been re-filed.

"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