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山东29条措施深化药品医疗器械监管改革,促进医药产业发展
Qi Lu Wan Bao· 2025-12-25 10:26
Core Viewpoint - The implementation of the "Implementation Opinions" by the Shandong Provincial Government aims to enhance the innovation capability, optimize the industrial structure, and strengthen the international competitiveness of the pharmaceutical industry in Shandong [1]. Group 1: Specific Measures - The "Implementation Opinions" outlines 29 specific measures across six areas, focusing on strengthening pharmaceutical innovation, optimizing the clinical trial ecosystem, deepening review and approval reforms, promoting clinical application, advancing international development, and enhancing quality supervision [2][3]. Group 2: Key Features - The "Implementation Opinions" emphasizes a systematic integration approach, creating a comprehensive policy framework that spans from research and development to usage, innovation to regulation, and domestic to international [4]. - It highlights innovation-driven strategies, proposing specific measures such as research subsidies, strategic investments, and pilot support to foster key areas like cutting-edge technologies and platform development [4]. - The initiative aims to optimize the business environment by reforming review and approval processes, enhancing clinical trial ecosystems, and improving inspection efficiency to reduce institutional transaction costs [4]. - It reinforces clinical application by expediting the market entry of innovative products, standardizing pharmaceutical committee processes, and optimizing medical insurance payment policies [4]. - The focus on open development includes practical measures for internationalization, such as targeted investment attraction, support for overseas expansion, and international certification [4]. - The "Implementation Opinions" also stresses the importance of maintaining safety standards by ensuring accountability, enhancing smart supervision, and strictly combating illegal activities to guarantee the safety and efficacy of pharmaceuticals and medical devices [4].