山东将全面深化药械监管改革，以全链条改革激发产业创新活力

Core Viewpoint - The Shandong Provincial Government has introduced a series of reform measures aimed at enhancing the regulatory framework for pharmaceuticals and medical devices, promoting high-quality development in the pharmaceutical industry [3][4]. Group 1: Reform Measures - The implementation opinions focus on addressing the challenges in the pharmaceutical industry by introducing breakthrough reform measures that stimulate innovation throughout the entire industry chain [4]. - A "one-stop" innovation service network will be established, covering provincial, municipal, and county levels, to accelerate the review and approval process for innovative drugs and medical devices [4]. - The regulatory mechanism will be optimized by integrating registration checks, production licensing, and quality management inspections to minimize disruptions to normal production [4]. Group 2: Industry Growth - The initiative emphasizes fostering new growth drivers in the industry by focusing on cutting-edge innovations such as gene and cell therapy, AI in pharmaceuticals, and high-end medical devices [4]. - Support will be provided for the development of traditional Chinese medicine (TCM) aimed at treating major diseases, including the establishment of a platform for the transformation of TCM into new drugs [4]. - The "Medical Device Spring Rain Action" will be launched to support the transformation of medical device innovations, particularly in areas like surgical robots and biomaterials [4]. Group 3: Clinical Transformation - The reform will enhance collaboration among various departments, creating a seamless connection between clinical trials, clinical use, and insurance coverage [5]. - Clinical trial processes will be optimized, encouraging qualified medical institutions to undertake trial projects and establishing incentive mechanisms [5]. - A green channel mechanism will be implemented for innovative drugs and medical devices, ensuring timely access for healthcare institutions to new products [5]. Group 4: Safety and Regulation - The initiative emphasizes strict regulatory measures to ensure safety in drug development and usage, adhering to the "four strictest" requirements [6]. - A smart regulatory platform utilizing big data and AI will be developed to ensure traceability throughout the supply chain [6]. - There will be a focus on enhancing risk monitoring and emergency response capabilities, alongside strict enforcement against illegal activities [6].