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

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.