国家药监局：进一步优化临床急需境外已上市药品审评审批

Core Viewpoint - The National Medical Products Administration (NMPA) of China is optimizing the review and approval process for urgently needed foreign drugs already on the market to meet the pressing clinical needs of patients [1][2]. Group 1: Review and Approval Process - The NMPA encourages applicants to conduct global synchronized research and simultaneous applications for urgently needed foreign drugs, including both original and generic drugs, which may qualify for priority review and approval [1]. - The review mechanism is being optimized to accelerate the approval speed, allowing applicants to utilize clinical data from both domestic and foreign sources, and submit necessary supporting materials for urgent clinical needs [2]. - Drugs that are included in the priority review and approval category will be managed separately by the Drug Review Center, with enhanced communication and guidance [3]. Group 2: Inspection and Registration - For rare disease drugs that are urgently needed but not yet available in China, applicants are encouraged to apply for registration inspection using a pre-inspection method, reducing the inspection time from 60 days to 40 days for sample inspections [3]. - The registration inspection timeline is also shortened from 90 days to 70 days when both standard review and sample inspection are conducted simultaneously [3]. - The NMPA is optimizing the registration verification process by integrating risk-based approaches to determine the method of inspection, whether on-site or remote [3]. Group 3: Import Channels - The NMPA is committed to maintaining a smooth temporary import channel for urgently needed drugs, particularly for rare diseases, to enhance efficiency and meet the clinical needs of medical institutions [3].