细胞与基因疗法将获“先进治疗药品”新身份，加速审评审批上市

Core Viewpoint - The article discusses the establishment of a regulatory framework for advanced therapy medicinal products (ATMPs) in China, aiming to enhance the quality of the industry and align with international standards [1][2][4]. Group 1: Definition and Classification - The draft document defines "advanced therapy medicinal products" as those developed, produced, and regulated according to pharmaceutical regulations, including cell and gene therapies [2][4]. - ATMPs in China are categorized into three main types: cell therapy medicinal products (CTMPs), gene therapy medicinal products (GTMPs), and others based on their material basis and active ingredients [2][6]. Group 2: Industry Development and Global Position - The advanced therapy sector is identified as a core area of life sciences, crucial for fostering future industries and promoting high-quality development in the bio-economy [3][4]. - As of 2024, China has made significant progress in CGT drug development, with 4 out of 17 global CGT therapies approved, and 6 out of over ten CAR-T products approved worldwide [3][4]. Group 3: Regulatory Challenges and International Coordination - The current lack of regulatory definitions and industry consensus in China poses challenges for the development, technical review, and regulation of advanced therapies [4][6]. - The draft aims to unify the naming, scope, and classification of advanced therapy products, facilitating faster reviews and approvals while enhancing international regulatory coordination [1][4]. Group 4: Specific Regulatory Provisions - The draft specifies that certain products, such as blood components and reproductive cells, are excluded from the definition of ATMPs [6]. - CAR-T therapies are classified as "ex vivo gene-modified cell products," differing from classifications by other global regulatory bodies, reflecting a focus on the material basis and characteristics of the products [6][7]. Group 5: Future Prospects and Inclusivity - The classification framework is designed to be forward-looking and inclusive, allowing for the integration of new technologies and products as they develop [7]. - The draft has incorporated feedback from over 70 industry experts and representatives, indicating a collaborative approach to regulatory development [7].