細(xì)胞治療（包括干細(xì)胞）是目前生物醫(yī)藥領(lǐng)域發(fā)展最快、最前沿的領(lǐng)域之一。細(xì)胞治療產(chǎn)品是從實(shí)驗(yàn)室培養(yǎng)的干細(xì)胞、組織和器官中提取的，被注射到病人體內(nèi)的生物技術(shù)產(chǎn)品。在分析國(guó)外情況的基礎(chǔ)上，認(rèn)為加強(qiáng)細(xì)胞產(chǎn)品制備和臨床應(yīng)用規(guī)范管理是勢(shì)在必行的大事。提出細(xì)胞治療產(chǎn)品和技術(shù)的監(jiān)管科學(xué)的5大要素，據(jù)此分析了我國(guó)發(fā)展的3大短板。最后，為加強(qiáng)法規(guī)、政策與科學(xué)監(jiān)管體系建設(shè)，促進(jìn)細(xì)胞治療產(chǎn)業(yè)和技術(shù)發(fā)展，提出發(fā)展細(xì)胞產(chǎn)品和技術(shù)應(yīng)用的監(jiān)管科學(xué)3點(diǎn)建議：一是發(fā)展細(xì)胞治療監(jiān)管科學(xué)的頂層設(shè)計(jì)的設(shè)想；二是在發(fā)展政策指導(dǎo)下，細(xì)胞產(chǎn)品研發(fā)體系和質(zhì)量標(biāo)準(zhǔn)的原則是產(chǎn)業(yè)發(fā)展的基礎(chǔ)和迫在眉睫的任務(wù)的問題；三是降低研發(fā)風(fēng)險(xiǎn)，明確細(xì)胞產(chǎn)品和治療技術(shù)的主體責(zé)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.