국내외 이종이식제제 제조 및 품질관리 기준 비교를 통한 국내 규정 개정 방안 연구

Study of the Improvement of Domestic Regulations through Comparison of Domestic and Foreign GMP Regulations for Xenotransplantation Products

Development of xenotransplantation products is being consistently attempted worldwide as one of the alternatives to meet the increasing demand of organ transplantation. Xenotransplantation products, as a type of advanced therapy medicinal products (ATMPs), they must comply with manufacturing and quality management standards (good manufacturing practice, GMP) in order to get a marketing authorization. However, the current domestic GMP standards for ATMPs are described focused on cell therapies and/or gene therapies and it is necessary to review whether the current standards can be applied to xenotransplantation products as well. The purposes of the present study are to identify the characteristics of xenotransplantation products that need to be included in the GMP standards, and to prepare internationally harmonized measures by comparing and analyzing the current domestic ATMP GMP standards. As a result, the characteristics of xenotransplantation products that need to be described in GMP standards were largely the definition and management of animals used in the manufacture of the products (“source animals”), and minimizing the risk of crosscontamination between the two species. The regulations or guides in the United States, the European Union, Japan provide the term “source animals” and requirements for the adequate facilities, ethical considerations, and so forth. In terms of minimizing the risk of cross-contamination, relevant descriptions were confirmed in the regulations of PIC/S, the United States, the European Union, and Japan. Taken together, considering revision of the current domestic GMP standards for ATMPs is highly suggested in order to meet the development demand and harmonize the regulation tools.