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国家药监局:推动“春雨行动”从试点省份探索转向全国常态化运行 加快产品上市进程
Di Yi Cai Jing· 2025-12-04 10:03
据国家药监局消息,12月3日,推进医疗器械临床研究成果转化暨"春雨行动"工作推进会在广州召开。 会议要求,各参与试点省份要准确把握"春雨行动"的关键环节,继续加强政策宣贯培训,做好项目征集 和评估筛选,积极开展分类指导服务,推动项目匹配对接,完善跨部门协同工作机制,强化注册服务能 力建设,推进以临床价值为导向的医疗器械源头创新,推动"春雨行动"从试点省份探索转向全国常态化 运行,加快产品上市进程。 (文章来源:第一财经) ...
推进医疗器械临床研究成果转化暨“春雨行动”工作推进会召开
人民财讯12月4日电,12月3日,推进医疗器械临床研究成果转化暨"春雨行动"工作推进会在广州召开。 会议要求,各参与试点省份要准确把握"春雨行动"的关键环节,继续加强政策宣贯培训,做好项目征集 和评估筛选,积极开展分类指导服务,推动项目匹配对接,完善跨部门协同工作机制,强化注册服务能 力建设,推进以临床价值为导向的医疗器械源头创新,推动"春雨行动"从试点省份探索转向全国常态化 运行,加快产品上市进程。 ...
广东启动“春雨行动”医疗器械临床研究成果转化工作
Zhong Guo Fa Zhan Wang· 2025-07-15 07:45
Core Viewpoint - The "Spring Rain Action" initiative aims to promote the transformation of clinical research results in medical devices, enhancing innovation and industrialization processes in Guangdong's medical device sector [3][4]. Group 1: Policy and Implementation - The "Spring Rain Action" is a significant measure led by the National Medical Products Administration (NMPA) to facilitate the transformation of innovative medical device research results [3]. - Guangdong has established a comprehensive implementation plan for the "Spring Rain Action," which includes setting clear objectives, standards, and mechanisms for clinical research result collection and evaluation [4][5]. - The province's drug regulatory authority has emphasized the importance of early intervention and tailored support for medical device projects to streamline the approval process [5]. Group 2: Industry Status and Achievements - As of June 2025, Guangdong has 8,983 medical device production enterprises and over 1.76 million registered products, leading the nation in both categories [2]. - The province has received approval for 25 innovative drugs and 48 innovative medical devices, showcasing significant breakthroughs in the industry [2]. - Guangdong is home to 250 tertiary hospitals and 50 high-level hospitals, providing a robust platform for clinical trials and research [2]. Group 3: Collaborative Efforts and Future Directions - The training session for the "Spring Rain Action" involved over 60 representatives from various medical and research institutions, fostering collaboration across the medical, academic, and regulatory sectors [6]. - The initiative aims to create a coordinated mechanism involving multiple stakeholders to enhance the transformation of clinical research results into practical applications [6]. - The provincial drug regulatory authority plans to leverage this training as a catalyst for further collaboration and innovation in the medical device field [6].
广东药械化生产企业总量全国第一
Guang Zhou Ri Bao· 2025-07-15 07:43
Core Insights - Guangdong Province has the highest number of pharmaceutical and medical device manufacturers in China, with a total of 8,983 companies and over 1.76 million registered products as of mid-2023 [1] - The "Spring Rain Action" initiative aims to enhance the transformation of clinical research results in medical devices, promoting innovation and industrialization in the sector [2] Group 1: Industry Overview - Guangdong leads the nation in the number of pharmaceutical, medical device, and cosmetic production companies, as well as in the stock of registered products and the number of approved innovative products [1] - The province has received approvals for 25 Class I innovative drugs and 48 innovative medical devices from the National Medical Products Administration in recent years [1] - Guangdong is home to 250 tertiary hospitals and 50 high-level hospitals, providing a strong clinical trial research platform [1] Group 2: Spring Rain Action Initiative - The "Spring Rain Action" is a key initiative led by the National Medical Products Administration to promote the transformation of innovative medical device research results [2] - The initiative focuses on collecting clinical doctors' innovative ideas and effectively connecting them with medical device research and development needs [2] - Guangdong has developed an implementation plan for the "Spring Rain Action," emphasizing the importance of this initiative for the high-quality development of the biopharmaceutical industry in the province [2]