In late October, China’s NMPA announced that they had started a new program in 2 locations to simplify the process for the approval of innovative drugs. “Advanced Acceptance Services” will become available for applications qualified for priority review or conditional approval as early as November 1, 2024 – following appropriate pre-application consultations.
These services offered by the NMPA’s Drug Review and Inspection Center and its branch offices in the Yangtze River Delta and Greater Bay Area focus on the resolution of procedural, regulatory, and documentation issues. Technical review issues are not under the scope of these services. Applicants can make appointments online via the Applicant’s Window on the Center for Drug Evaluation (CDE) website.
Face-to-face consultations are offered every Wednesday to provide timely feedback on the submitted documents to help applicants have a smoother application process. This initiative is aimed at streamlining the approval processes, fostering innovation, and facilitating quicker access to high-quality medicines for Chinese citizens in these two regions.
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.