China’s National Medical Products Administration has issued a Pilot Work Program to fast-track innovative drug clinical trial approvals. According to the notice, the normal review period has been cut from 60 to 30 working days, and this change will be applied to Class I innovative drugs defined as new-to-the-world drugs. Cell and gene therapies as well as vaccine products are excluded.
This pilot program has been restricted to Beijing and Shanghai, where only institutions with more sophisticated clinical research experience are eligible. In addition, applicants must have completed at least three previous innovative drug trials, with the same criteria applying to the institutions.
Applicants who intend to take part in this pilot program will be required to submit documents such as trial protocols and risk management plans to provincial Chinese medical products administrations (MPAs), which will confirm eligibility within five business days. Trials should start within 12 weeks once approved.
This new scheme, which should last for one year, will be up for a mid-term review in January 2025 and a final evaluation in July. Then, it will be determined whether a rollout nationwide is recommended. The program is part of China’s efforts to enhance its pharmaceutical innovation and clinical research capacity.
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.