药械创新“山东速度”：审评时限缩7成，1类创新药获批量增10倍

Group 1 - The core viewpoint of the article highlights Shandong's efforts to promote high-quality development in the pharmaceutical industry during the "14th Five-Year Plan" period through various supportive policies and measures [3][4]. - Shandong has introduced a series of policies, including a maximum funding subsidy of 30 million yuan for clinical trials of Class 1 innovative drugs, and has implemented 133 high-value supporting measures to enhance the research and development capabilities of innovative drugs and medical devices [3][4]. - Since the beginning of the "14th Five-Year Plan," Shandong has approved 10 Class 1 innovative drugs, which is ten times the number approved during the "13th Five-Year Plan," and has seen a compound annual growth rate of nearly 40% in new drug approvals [3][4]. Group 2 - In terms of drug regulation reform, Shandong is focused on creating a flat service system that connects various levels of governance, actively integrating into the Beijing-Tianjin-Hebei national strategy [4]. - The province has been approved as a pilot for the national drug supplementary application review and approval process reform, significantly reducing review times for innovative technology applications and major process changes from 200 working days to 60 working days, a reduction of 70% [4]. - The establishment of provincial drug regulatory review and inspection sub-centers in cities like Jinan, Yantai, and Heze has led to the efficient handling of over 5,000 items, with average processing times reduced by more than 50% [4]. Group 3 - Shandong is committed to both "going out" and "bringing in" strategies to enhance cooperation in the pharmaceutical industry [5]. - The province has organized pharmaceutical industry promotion events in Europe and Central Asia, resulting in 26 signed cooperation projects, leveraging its complete pharmaceutical industry chain and strong manufacturing capabilities [5]. - By building a comprehensive platform for innovation and regulatory services, Shandong has attracted high-profile international pharmaceutical projects from companies like AstraZeneca, Bayer, and Bausch & Lomb, establishing itself as a new highland for the openness of the pharmaceutical industry [5].