加速引入临床急需境外新药、好药，国家药监局优先审评审批扩围

Core Viewpoint - The National Medical Products Administration (NMPA) has announced a new policy to expedite the approval process for urgently needed foreign drugs that are already on the market, expanding the scope to include both original and generic drugs, and allowing for potential exemptions from clinical trials for certain applications [1][3]. Group 1: Policy Changes - The NMPA's recent announcement emphasizes a clinical value-oriented approach, encouraging global synchronized research and application for drug approvals in China [1][2]. - The scope of priority review and approval has been broadened to include urgently needed foreign drugs for chronic and geriatric diseases, in addition to major and rare diseases [2][3]. - The NMPA will not limit the priority review process to a specific list of drugs, recognizing the rapid changes in drug development and clinical needs [3]. Group 2: Clinical Trial Exemptions - For eligible foreign generic drugs, the NMPA has stated that clinical trials may be waived, allowing companies to directly submit applications for drug marketing authorization [3]. - The announcement outlines that data from foreign registrations, including clinical data and safety monitoring reports, can support applications for priority review [3]. Group 3: Rare Disease Focus - The issue of "foreign drugs available but not in China" for rare disease patients is a key focus of the announcement, addressing the economic burden of high sampling ratios for rare disease drugs [4][5]. - The NMPA has proposed reducing the sample size required for registration inspections for rare disease drugs, from three times the inspection amount to two times, to alleviate the burden on companies [5]. - The announcement also aims to streamline the temporary import pathways for urgently needed rare disease medications, enhancing efficiency to meet clinical demands [5].