細胞治療（包括干細胞）是目前生物醫(yī)藥領域發(fā)展最快、最前沿的領域之一。細胞治療產(chǎn)品是從實驗室培養(yǎng)的干細胞、組織和器官中提取的，被注射到病人體內的生物技術產(chǎn)品。在分析國外情況的基礎上，認為加強細胞產(chǎn)品制備和臨床應用規(guī)范管理是勢在必行的大事。提出細胞治療產(chǎn)品和技術的監(jiān)管科學的5大要素，據(jù)此分析了我國發(fā)展的3大短板。最后，為加強法規(guī)、政策與科學監(jiān)管體系建設，促進細胞治療產(chǎn)業(yè)和技術發(fā)展，提出發(fā)展細胞產(chǎn)品和技術應用的監(jiān)管科學3點建議：一是發(fā)展細胞治療監(jiān)管科學的頂層設計的設想；二是在發(fā)展政策指導下，細胞產(chǎn)品研發(fā)體系和質量標準的原則是產(chǎn)業(yè)發(fā)展的基礎和迫在眉睫的任務的問題；三是降低研發(fā)風險，明確細胞產(chǎn)品和治療技術的主體責任。

Cell therapy (including stem cell therapy) is one of the fastest developing and most advanced fields in biomedicine. Cell therapy products are biotech products that are derived from stem cells, tissues and organs grown in the lab and injected into patients. Based on the analysis of the situation abroad, it is necessary to strengthen the preparation and clinical application of cell products. This paper puts forward five key elements of the regulatory science of cell therapy products and technologies, and analyzes the three shortcomings of China's development. Finally, in order to strengthen the construction of laws and regulations, policies and scientific supervision system for promoting the development of cell therapy industry and technology, authors put forward three scientific suggestions on the development of cell products and technology applications. First, develop the top-level design idea of cell therapy regulatory science; second, under the guidance of development policies, the principle of cell product research and development system and quality standards is the foundation of industrial development and an urgent task; and third, to reduce the risk of research and development and define the main responsibility of cell products and therapeutic technologies.