苏北人民医院临床药理研究中心通过专业备案检查

Core Insights - The Suzhou Northern People's Hospital Clinical Pharmacology Research Center successfully passed the professional filing inspection for its bioequivalence testing specialty, marking a significant advancement in the hospital's clinical trial capabilities and contributing to the high-quality development of regional drug clinical trials [1][2]. Group 1: Inspection and Achievements - The Clinical Pharmacology Research Center underwent its first on-site inspection by experts from the Jiangsu Provincial Drug Supervision Administration on November 11-12, 2025, demonstrating thorough preparation by the research team led by Professor Shu Yusheng [1]. - The center currently has 28 drug clinical trial specialties and 41 medical device clinical trial specialties, capable of undertaking various clinical trial projects [1]. Group 2: Future Plans and Development - Following the successful filing of the bioequivalence testing specialty, the center aims to enhance its clinical trial quality management system and promote standardized processes, thereby elevating the hospital's research and clinical trial standards [2]. - Since its establishment in December 2023, the center has adhered to national regulations and quality management standards, with a facility covering approximately 3,600 square meters, equipped with 72 beds and 2 emergency beds [2]. - The center's research team consists of 16 staff members, including 10 with senior titles and 2 with intermediate titles, and features members from national and provincial drug clinical trial expert databases [2]. Group 3: Next Steps - The center plans to actively advance the filing application for its Phase I drug clinical trial specialty, aiming to undertake more high-quality innovative drug Phase I clinical trial projects [3].