北京“两区”建设五年来，共推动17款创新药获批上市

Group 1 - Beijing has approved 17 innovative drugs and 54 Class III innovative medical devices in the past five years, ranking among the top in the country [1] - A comprehensive implementation plan for the biopharmaceutical industry chain was developed, proposing 50 specific measures across five areas: market access, supply chain, clinical application, international cooperation, and key element assurance [1] - Beijing established a provincial-level innovation service station for drugs and medical devices, and introduced a "white list" system for importing research and development materials [1] Group 2 - In 2024, a green channel for the import approval of urgently needed clinical drugs and devices will be established, focusing on rare disease medications [2] - A total of 23 clinical urgently needed drug imports have been approved in the past year, benefiting over 2,000 patients [2] - Drug review and approval reforms have reduced the approval time for innovative drug clinical trials from 60 days to 30 days, with some projects approved in as little as 18 working days [2] Group 3 - Beijing has created an integrated sampling inspection model for imported drugs, achieving customs clearance and sampling within 24 hours [3] - Over the past five years, the Tianzhu port has completed 15,000 customs clearances and over 5,100 sampling batches, with annual increases in clearance numbers [3] - From January to May, 613 batches of imported drug inspections were accepted, with a year-on-year value increase of 58% [3]