In mid-September, China’s National Medical Products Administration (NMPA) launched a 30-day review and approval pathway for investigational new drug (IND) applications to speed up clinical trial initiation for innovative pharmaceuticals. This pathway supplements the existing 60-day default approval pathway established in 2019.
The 30-day pathway will apply to applications for innovative traditional Chinese medicines, small molecules, and Category I biologics, including antibodies, therapeutic proteins, and gene-based products that have not been marketed in China already. The therapeutic areas that qualify for this pathway include oncology, cardiovascular, cerebrovascular, and metabolic diseases. In addition, going forward, trials must be initiated within three months of IND approval.
Furthermore, the new pathway enhances standards for the preparation and oversight of clinical trials. For a 30-day review, applicants must submit more documents than those required for the 60-day pathway and prepare a risk management plan specifically for China. This plan must address participant safety and data compliance issues and must be implemented by the Principal Investigator.
This initiative is a result of a one-year pilot program recently implemented in major Chinese cities and is expected to increase the quality of regulatory oversight while expediting patient access to new drug therapies.
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.