Conditional drug approval in China can be granted if the drug meets certain criteria – 1. it helps patients more than approved therapies, 2. has the same efficacy as existing drugs but has fewer side effects, 3. can help with a public health crisis, etc. Now, the CDE has outlined changes to China’s conditional approval process. First, conditional approval in China does not detail, as the US FDA does, the indications for significant diseases. The current wording in China outlines drugs for conditional approval only if the disease is life-threatening and will lead to death if not treated quickly. China’s conditional approval also mainly focuses on cancer drugs and not other serious diseases. The CDE is also recommending shortening the timeframe for communication meetings for conditional drugs (less than 60 days). In addition, the CDE is also suggesting reducing the timeframe of post-marketing studies and further clarifying post-marketing studies, systems, and policies.
Since China’s conditional approval went into effect in 2020, over 50 drugs have received conditional approval with 5 of them receiving full approval. The bulk of these drugs is for cancer.
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.
Source used in the article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926957/