中国台湾地区细胞治疗产品临床试验监管及对大陆地区的启示

Clinical Trials Supervision of Human Cell Therapy Product in Taiwan Province of China and the Implications for Mainland China

关键词:  细胞治疗产品  临床试验  临床应用  质量控制  建议

Key words:  human cell therapy product  clinical trials  applying clinical  quality control  approaches

摘要:

目的 提高大陆地区细胞治疗产品临床试验管理水平，加快产品转化，完善产品监管体系。方法 对中国台湾地区细胞治疗产品临床试验相关法律、法规等进行系统回顾，结合有关文献，分别从临床试验监管、细胞治疗产品制备过程的质量控制以及临床应用3个方面进行分析，总结中国台湾地区细胞治疗产品临床试验监管对大陆地区的启示。结果 大陆地区应尽快建立系统的法律与监管框架，实施细胞治疗产品分类管理，与此同时，还应加强细胞治疗产品制备过程的质量控制。结论 细胞治疗产品作为一种前沿的医疗技术，其临床应用范围十分广泛，但由于其复杂的产品特性，使得细胞治疗产品在临床应用时仍存在较高的风险性。建议建立科学的监管体系，完善临床试验管理，确保细胞治疗产品安全有效。

Abstract:

OBJECTIVE To improve the management level of clinical trials for human cell therapy product, speed up the transformation of human cell therapy product, and perfect human cell therapy product supervision system in mainland China. METHODS Relevant laws and regulations regarding clinical trials was reviewed in Taiwan province of China. Then, clinical trial supervision, quality control of human cell therapy product preparation and clinical application were analyzed respectively. Finally, the enlightenment of clinical trial supervision of human cell therapy products in Taiwan province of China was summarized to mainland China. RESULTS Mainland China should accelerate the process of building a systemic regulatory framework, execute the categorized management on human cell therapy product, and reinforce the process of quality control during human cell therapy product manufacture. CONCLUSION Human cell therapy product act as one of the latest medical technology, and have broad application in clinical applications. However, due to complex product features of human cell therapy product, its utilization in clinical applications is still at risk. It is suggested that ensure the safety and effectiveness of human cell therapy product and benefit mankind, establish a scientific supervision system and continuously improve the management on clinical trials.