In late July, China announced a new trial program, starting in August 2024 for one year, to reduce the IND review time for innovative drugs in China to 30 days. Previously, the IND review time was 60 days and if an applicant did not hear back from the Chinese regulator, the applicant could start their clinical trial – no objection meant IND approval. The goal of this trial program is to expedite the start of clinical studies and the development of new drugs. It is expected that at least 10 drugs will be developed in each of the approved provinces under this new pilot program. Over the last few years, the number of domestic and foreign IND applications has grown very quickly.
With respect to this new pilot program, please keep in mind that it will not apply to new vaccines and cell/gene therapies. Also, clinical trial sites and sponsors need to meet certain criteria to be eligible to participate. Sponsors need to have received approval for at least 3 clinical trials before they can apply for this new pilot IND program. In addition, sponsors will need to have extensive risk management plans in place. Clinical trial sites will need to be national centers for drug development and principal investigators must have good clinical trial experience with innovative drugs. Also, clinical sites must get approval from the Center for Drug Evaluation (CDE) before initiating local trials.
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.