境外已上市药品
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国家药监局:境外已上市药品在我国获批上市后,对符合要求的获批前商业规模批次产品,允许进口并上市销售
Mei Ri Jing Ji Xin Wen· 2025-09-30 03:12
每经AI快讯,9月30日,国家药监局发布公告,境外已上市药品在我国获批上市后,对符合要求的获批 前商业规模批次产品,允许进口并上市销售。相关产品应当属于下列情形之一:(一)原研药品或者改良 型药品。(二)《国家短缺药品清单》《国家临床必需易短缺药品重点监测清单》《鼓励仿制药品目录》 《鼓励研发申报儿童药品清单》列明的药品。(三)适应症包括《罕见病目录》列明疾病的药品(四)在我 国获批上市前,按照《临床急需药品临时进口工作方案》获准临时进口的药品。(五)依据《药品注册管 理办法》,适用药品加快上市注册程序在我国获批上市的药品。(六)国务院药品监督管理部门规定的其 他药品。 ...
江苏省:支持脑机接口设备、医用机器人等前沿技术产品研发
Zheng Quan Shi Bao Wang· 2025-08-28 14:52
Core Viewpoint - Jiangsu Province has issued policies to promote deep reforms in drug and medical device regulation, aiming to enhance the high-quality development of the pharmaceutical industry [1] Group 1: Support for Innovation - The policies emphasize support for the research and development of innovative products, focusing on areas such as innovation, clinical needs, and rare disease treatments [1] - A series of provincial science and technology projects will be implemented to support the development of cutting-edge medical technologies, including cell and gene therapy drugs, foreign-approved drugs, radioactive drugs, medical robots, and brain-computer interface devices [1] Group 2: Enhancement of Testing and Monitoring Capabilities - The initiative includes advancing the construction of testing platforms in emerging fields such as brain-computer interfaces and artificial organs [1] - The goal is to create advantageous testing projects in the field of medical acoustics [1]