China -  Chinese law firm

What recommendations can be made to reduce the review time?

1. The review process may be simplified and reduced, which would minimize the time lag between the various steps in the approval process. Requirements of Phase I clinical trials should be exempted. Although China is beginning to accept foreign clinical trial data and some Class III New Drugs are exempt from Phase I trials, however, SDA still requires Phase I trials whenever the Asian ethnic data comprises less than half of the data package. On average, Phase I clinical trials take 6 months to complete in China. This, in effect, severely limits international trials in China. 2. According to the Notice on Import Drug Registration promulgated in February 2002, the technical review by CDE (Center of Drug Evaluation) could proceed simultaneously with quality inspection by NICPBP. This is a significant improvement as in the past CDE could only initiate technical review after receiving the inspection report from NICPBP. 3. Data requirements for a clinical trial application should be consistent with international requirements and focus on safety and efficacy. Currently they exceed the review purpose during the clinical trial. The purpose of requiring manufacturing information should be for the limited purpose of ensuring that the company is able to adequately produce a consistent quality of drug. ICH has established a CTD (common technical documentation) which Chinese authorities should reference as it will reduce approval time and lead to a better use of resources.

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