国家药监局:境外已上市药品在我国获批上市后,对符合要求的获批前商业规模批次产品,允许进口并上市销售
Mei Ri Jing Ji Xin Wen·2025-09-30 03:12

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced that foreign drugs approved for sale in China can be imported and marketed if they meet specific criteria, which may enhance the availability of essential medications in the market [1] Group 1: Approval Criteria - Approved foreign drugs must fall into one of the following categories: original or modified drugs [1] - Drugs listed in the National Shortage Drug List, National Key Monitoring List for Clinically Essential Drugs, Encouraged Generic Drug List, or Encouraged Research and Application List for Pediatric Drugs [1] - Drugs indicated for diseases included in the Rare Disease List [1] - Drugs that were temporarily imported under the Temporary Importation Work Plan for Clinically Urgent Drugs before being approved for sale in China [1] - Drugs that qualify for expedited registration procedures according to the Drug Registration Management Measures [1] - Other drugs as specified by the State Council's drug regulatory authority [1]