Opportunities, positioning, and development pathways for the Department of Transfusion Medicine to proactively undertake cell and gene therapy under the Regulations on the Clinical Research and Translation of New Biomedical Technologies
10.13303/j.cjbt.issn.1004-549x.2026.07.003
- VernacularTitle:《生物医学新技术临床研究和临床转化应用管理条例》实施背景下输血医学科主动承接细胞与基因治疗的机遇、定位与发展路径
- Author:
Lili CHEN
1
;
Jinjin ZHANG
1
;
Yonggang ZHANG
2
;
Yanchao XING
1
;
Jia YU
2
Author Information
1. Department of Transfusion Medicine, Xinjiang Military Region General Hospital, Urumqi 830000, China
2. Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Peking Union Medical College, Chengdu 610052, China
- Publication Type:Journal Article
- Keywords:
new biomedical technologies;
transfusion medicine;
cell and gene therapy;
quality control
- From:
Chinese Journal of Blood Transfusion
2026;39(7):832-839
- CountryChina
- Language:Chinese
-
Abstract:
The official implementation of the Regulations on Clinical Research and Translation of New Biomedical Technologies (State Council Decree No.818, hereinafter referred to as the "Regulations") marks a new stage of legal governance, standardization, and whole-chain regulation for emerging biomedical fields such as cell and gene therapy (CGT) in China, exerting a profound impact on the development of transfusion medicine as a discipline. Within the framework of the core regulatory systems established by the Regulations, and drawing upon the extensive experience of transfusion medicine in comprehensive quality control, cell processing and handling, ethical compliance, and clinical translation, this study systematically elucidates the intrinsic alignment between transfusion medicine and CGT with respect to technical workflows, quality control rationale, and management systems. It further clarifies the discipline-specific advantages of the department of transfusion medicine to proactively undertake CGT engagement, while analyzing current shortcomings and transformational bottlenecks. By leveraging the existing institutional framework, the department of transfusion medicine is well positioned to evolve into a core platform for whole-process quality control and a pivotal hub for in-hospital clinical translation of CGT. However, this transformation must concurrently address multiple challenges, including heightened compliance responsibilities, lagging technical infrastructure, a shortage of interdisciplinary talent, and increasingly stringent standards for clinical research and translation. The Regulations provide a legal basis and policy support for the department of transfusion medicine to transcend its traditional, singular function of blood safety assurance and establish a synergistic development model integrating blood safety and cell therapy. Therefore, the department of transfusion medicine should proactively align with regulatory requirements, refine whole-process compliance systems, upgrade technical platforms, and cultivate interdisciplinary professionals to achieve high-quality transformative development as a core supporting discipline for biotherapy.
