인체세포 기반 융복합 의료제품의 최신 규제 동향

Cell-scaffold combination products are being developed in various forms due to the recent increase in demand for regenerative medicine and the expansion of the application field of cell research. Cell-scaffold combination products are mainly used to regenerate, repair or replace cells or tissues of the human body. Because cells are manufactured through the process of acquiring new structural properties, biological activities, or physiological functions through binding with scaffolds, Its structure and function are complex. Considering that the characteristics of a cell-scaffold combination products have a decisive influence on the function and production of the product, it is important to confirm the safety and effectiveness of the product. In order to optimize the quality of these products, it is necessary to verify the characteristics of each cell and scaffold as well as the cell-scaffold interaction and product-specific verification of the functionality of the finished product before components are manufactured as a composite. In the United States, cell-scaffold combination products are referred to as ‘human cells, tissues, or cell/tissue use products (HCT/PS)’, in Europe, they are referred to as advanced therapy medicinal products(ATMP), and in Japan, they are called products such as regenerative medicine. In this way, not only are the terms used to designate products different, but also the content that regulates the product group in each country is different. Therefore, this paper examines the regulatory status of human cell-based combination products in Korea and the regulatory trend of human cell-based combination products in developed countries, and makes legislative suggestions for rational regulation of human cell-based combination products.