山东出台意见深化药品医疗器械监管改革

Core Viewpoint - The Shandong Provincial Government has issued an implementation opinion 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 enhancing drug safety and industry development [1][2]. Group 1: Key Measures - The implementation opinion outlines 29 measures across six areas to strengthen the cultivation of pharmaceutical innovation, support cutting-edge technology, enhance innovation platform construction, and promote the transformation of innovative drugs and devices [2]. - It aims to optimize the clinical trial ecosystem by encouraging medical institutions to undertake trials, improving the efficiency of ethical reviews, promoting the application of AI technology, and enhancing institutional management and services [2]. - The reform of review and approval processes is emphasized, including proactive alignment with the National Medical Products Administration, support for generic drug services, and the promotion of smart regulation for traditional Chinese medicine [2]. Group 2: Promotion and Internationalization - The opinion promotes the clinical use of innovative products by establishing a catalog of innovative products, accelerating the listing process, and improving the medical insurance payment mechanism [2]. - It encourages the international development of the industry through targeted investment attraction, supporting the export of raw materials and formulations, and enhancing international cooperation [2]. - There is a focus on strengthening quality supervision throughout the entire process, ensuring corporate responsibility, enhancing smart regulatory capabilities, and cracking down on illegal activities [2].