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Press Release

60 Day Window for Clinical Trial Approval Official, says George Clinical, a leading Asia-Pacific CRO

George Clinical
Posted on: 09 Aug 18

9 AUGUST, 2018 – (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."

About George Clinical

George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities differentiated by scientific leadership, innovation and extensive investigator networks. With staff operating in 15 countries, and with significant operations in the USA, China, India and the broader Asia Pacific region, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials.

For more information, contact:

Philip Gregory

Managing Director China

https://www.georgeclinical.com

pgregory@georgeclinical.com

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Follow us on LinkedIn: https://www.linkedin.com/company/george-clinical-pty-ltd

 

Editor's Details

Michael Sydes
George Clinical
www.georgeclinical.com
+61 2 8052 4300
msydes@georgeclinical.com

Last updated on: 09/08/2018

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