Core Viewpoint - The Shandong Provincial Government has issued a policy document aimed at deepening the reform of drug and medical device regulation to promote high-quality development in the pharmaceutical industry, marking a significant step in balancing drug safety and industrial growth [6][11]. Group 1: Policy Implementation - The document outlines 29 measures across six key areas to enhance the innovation and development of the pharmaceutical industry [7]. - It emphasizes the importance of drug and medical devices as critical goods related to public health and safety, as well as economic development [4]. Group 2: Key Measures - Strengthening the cultivation of pharmaceutical innovation by supporting cutting-edge technology, enhancing innovation platforms, and promoting the transformation of innovative drugs and devices [7]. - Optimizing the clinical trial ecosystem by encouraging medical institutions to undertake trials, improving ethical review efficiency, and applying AI technology [8]. - Deepening review and approval reforms, including proactive engagement with national drug regulatory bodies and supporting segmented production of drugs [9][10]. Group 3: Industry Growth and Internationalization - Promoting the international development of the industry through targeted investment attraction and enhancing international cooperation [9]. - Encouraging the clinical promotion and use of innovative products by establishing product directories and improving insurance payment mechanisms [8]. Group 4: Quality Supervision - Strengthening quality supervision throughout the entire process, ensuring corporate responsibility, and enhancing smart regulatory capabilities [10][13]. - Implementing a comprehensive regulatory framework to ensure drug safety and efficacy, utilizing big data and AI for monitoring [13]. Group 5: Collaborative Efforts - Enhancing collaboration among various departments such as technology, health, and drug regulation to create a seamless connection between clinical trials, usage, and insurance coverage [12]. - Establishing a mechanism for mutual recognition of ethical reviews in multi-center clinical trials to reduce costs and time for enterprises [12]. Group 6: Future Directions - The Shandong Provincial Drug Administration will work with relevant departments to ensure drug safety and support the high-quality development of the pharmaceutical industry [13].
研发有支持、转化有通道、使用有保障,山东为创新药械挂网开通绿色通道