江苏省药监局核查中心助力多个创新药获批上市

Core Insights - Recent approvals of innovative drugs in Jiangsu Province provide new treatment options for patients, including chemical and traditional Chinese medicine products [1][2] - The Jiangsu Provincial Drug Administration is enhancing support for innovative drug development and market entry [1][2] Group 1: Innovative Drug Approvals - Several innovative drugs, including chemical class 1 drugs and traditional Chinese medicine, have been approved for market entry, expanding treatment options for patients [1] - Specific drugs approved include Marcilosavir tablets, Lisatoclav tablets, and others [1] Group 2: Support Mechanisms - The Jiangsu Provincial Drug Administration has implemented a "one-on-one" service mechanism for each innovative drug applicant, focusing on production risks and submission processes [1] - A combined inspection approach has been adopted to reduce the frequency of inspections for companies, streamlining the process [1] - Enhanced communication channels have been established to ensure timely responses to inspection needs and improve overall efficiency [1] Group 3: Future Initiatives - The Jiangsu Provincial Drug Administration plans to continue its efforts with higher standards and better services to expedite the availability of more innovative drugs for patients [2]