The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released a notification last week, announcing that marketing filings for innovative drugs and varieties that have been confirmed to receive priority review and conditional approval statuses will be given precedence in processing, effective as of November 1, 2024.
Applicants may apply for advanced services regarding acceptance-related issues to the CDE, the CDE Yangtze River Delta branch, or the CDE Greater Bay Area branch prior to filing. The advanced acceptance service primarily addresses policy and regulatory issues, application procedures, and supporting documents associated with the acceptance of marketing authorization applications for innovative drugs and varieties that are eligible for priority review and approval procedures and conditional approval procedures after communication and confirmation, excluding technical review-related issues. Every Wednesday is designated as the open day for face-to-face acceptance of advanced services. The CDE and its two branches will communicate with applicants for appointment applications submitted within 5 days that fall within the scope of advanced services.- Flcube.com
