In late October, the Chinese CDE outlined a strong recommendation for the review of clinical trials in China before they occur. In the past, the CDE mentioned the need for clinical trial sponsors to consult with them but recently, this recommendation has become more of a requirement. For a communication meeting, topics can include things like – 1. Safety and technical issues during breakthrough drug development, 2. Does existing research data support a China clinical study, 3. Are post-marketing controls sufficient, etc. The best time to initiate a CDE communication meeting is after your completion of Phase 2 trials. Hopefully, by completing this CDE meeting, the chance of problematic issues with your China clinical trial and IND submission will be minimized. Without a communication meeting, Sponsors also risk not getting their clinical trial approved within 60 days. In addition, complete trial protocols must be submitted to the CDE. If protocols are incomplete or have issues with safety, the CDE will not proceed.
Written by: Ames Gross – President and Founder
Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://clinregs.niaid.nih.gov/country/china/united-states#:~:text=Per%20the%20NMPA%2DNo50%2D2018,of%20conducting%20the%20clinical%20trial.