인체세포ㆍ조직이용 의료제품 등의 규제에 관한 국내외 규정 비교 및 안전관리 개선방안 연구

Comparative studies on the regulations of human cellular and tissue-based medical products for improvement of safety management

Over the past several decades, human-derived cells, tissues, and cell- and tissue-based therapies have contributed to essential body function regeneration in the absence of effective alternative medicine substitute. This study reviewed strength and weakness of the regulation related to human-derived cells, tissues based pharmaceutical products compared to the US regulation, and suggested points for improvement classified into three categories. First, it is necessary to supplement regulations and guidelines on donor eligibility for pharmaceutical products. Second, there is a need to integrate regulations related to classify pharmaceutical product into biologics, device, and combination products. Finally, there is a need to develop and supplement the traceability of biological traces and the regulations for biological monitoring systems of pharmaceutical products. Collectively, it would be necessary to revise the regulations and the guidelines for the approval, manufacture, management and tracking of human cell/tissue derived pharmaceutical products by collecting opinions from researchers, industry, and clinical health care workers with a systematic long-term goal.