审评审批制度改革

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山西对临床急需药品医疗器械实行即收即检
Zhong Guo Fa Zhan Wang· 2025-06-13 09:35
Core Points - The provincial government is implementing reforms to accelerate the approval process for innovative medical devices and drugs, including establishing a green channel for priority reviews and compressing inspection timelines to enhance market access [1][2] Group 1: Approval Process Optimization - The provincial drug regulatory authority has introduced measures to optimize the review and approval mechanism, including a proactive approach with tailored strategies for each product and dedicated support teams [1] - The approval process for drug changes has been streamlined, reducing the minimum processing time for site changes from 195 days to 105 days, achieving an overall time reduction of over 40% [1] Group 2: Inspection and Registration Improvements - The registration inspection for low-risk drug varieties has been optimized, with the required batch quantity for inspection reduced from three times to two times the full inspection quantity [2] - The inspection timeline for registered medical devices has been compressed to 20 working days, and emergency approvals are being implemented to expedite the process for urgently needed medical devices and drugs [2] Group 3: Focus on Rare Diseases and Urgent Needs - The approval process for drugs and medical devices related to rare diseases has been expedited, with the number of required inspection batches reduced from three to one, and the batch quantity requirement also decreased [2] - Clinical urgent medical devices are prioritized in the approval process, with the approval timeline reduced from 58 working days to 30 working days [2]