政府新闻
上海市首个细胞治疗药物质量管理指南发布 2024-11-13
The city's first guide to quality management of cell therapy drugs used in medical institutions was released on Tuesday, providing standardized guidance for the use of innovative drugs and ensuring the use of safe and reliable drugs.
The guide was released by the Xuhui District Administration for Market Regulation and 10 medical institutions during the Cell and Gene Therapy Drug Innovation and Clinical Development Forum, which is part of the 2024 Shanghai International Biopharmaceutical Industry Week.
The guide is released during the Cell and Gene Therapy Drug Innovation and Clinical Development Forum.
As a personalized live cell drug, CAR-T drugs have been successfully applied to the clinical treatment of hematopoietic system malignant tumors, triggering widespread attention.
Currently, Shanghai has three CAR-T drugs approved by the National Medical Products Administration for market launch, accounting for half of the country's total, and it has nearly 20 medical institutions that are using or about to use CAR-T drugs in clinical practice, leading the nation.
However, how to ensure the quality, safety and efficacy of a drug that costs 1.2 million yuan (US$166,117) per dose is the most concerning issue for many patients using CAR-T drugs in clinical practice, officials noted.
Source: Shanghai Daily
