审评服务改革
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省级审评服务搬进生产一线
Da Zhong Ri Bao· 2025-12-19 01:00
Core Viewpoint - The establishment of the first batch of review and inspection sub-centers in Jinan, Heze, and Yantai represents a significant reform by the Shandong Provincial Drug Administration, aimed at enhancing the efficiency and accessibility of provincial-level review services for the pharmaceutical industry [2][3]. Group 1: Service Efficiency Improvement - The new sub-centers allow companies to obtain drug production licenses in as little as 15 working days, significantly reducing the previous processing time of over a month [2]. - The Jinan sub-center has taken on 45 provincial-level powers, enabling one-stop processing for core business areas such as drugs and medical devices [3]. - The approval process for medical device internet information service registration has been expedited, with some cases completed in just one day, four days faster than the statutory limit [3]. Group 2: Tailored Support for Companies - Each sub-center is transitioning from passive acceptance to proactive support, providing tailored guidance to companies based on their specific needs [3]. - The Jinan sub-center has assisted seven innovative drugs and medical devices in obtaining approval this year, including the first class of innovative drug in the province [4]. - The Yantai sub-center has helped two innovative drugs enter the priority review and approval process at the National Drug Review Center [4]. Group 3: Industry Development and Future Plans - The Shandong Provincial Drug Administration aims to support the development of innovative drugs and medical devices as part of the "14th Five-Year Plan" [4]. - The administration's leadership emphasizes the commitment to high-quality development, with plans to continue enhancing services and measures to empower the pharmaceutical industry [4].