上海出台若干措施全面深化药械监管改革

Core Viewpoint - Shanghai has issued measures to promote high-quality development in the pharmaceutical industry through regulatory reforms, innovation support, and enhanced approval processes [1] Group 1: Regulatory Reforms - The measures include 22 initiatives focusing on regulatory reforms to activate enterprise development and cultivate new production capabilities [1] - Optimization of the change process and guidelines for already listed drugs is proposed, along with pilot programs for segmented production of biological products [1] - The measures aim to deepen the pilot work for self-developed in vitro diagnostic reagents in medical institutions [1] Group 2: Industry Innovation - The initiatives emphasize enhancing service efficiency to promote industry innovation and accelerate regulatory support [1] Group 3: Approval Acceleration - The measures propose to improve the registration review efficiency for Class II medical devices, streamline consultation pathways, and enhance the quality of application materials [1] - The average registration cycle for first-time Class II medical devices is targeted to be compressed to within 6 months [1] Group 4: Integration and Standards - The focus is on strengthening the dual drive of standards and technology to seize new market opportunities [1]