Conditional Pharmaceutical Approval in China, New CDE Comments

In China, there are basically four expedited approval pathways – Priority, breakthrough, special, and conditional drug review. A conditional NDA/BLA approval can be achieved for drugs with sufficient clinical efficacy data to predict the clinical value in the treatment of severe life-threatening and unmet medical needs. Through the end of 2022, about 40 new drug applications have received conditional approval.

Even after conditional approval is made for a specific indication, other applicants with the same indication can apply for conditional approval after they finish key clinical trials. This is because the first conditional approval may not succeed in confirmatory studies to get full approval in China. However, if a conditional approval for the first applicant receives full approval in China, it is likely subsequent conditional approval applications for the same indication will be rejected. In this case, subsequent conditional approval applications for the same indication would not receive priority review either.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM 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.