Study of the Improvement of Domestic Regulations through Comparison of Domestic and Foreign GMP Regulations for Xenotransplantation Products
Hye Jin Cha*,#, Yeung Bae Jin*, Yoo Kyung Kang**, Junhyun Shin***, and Min Joung Choi***
*Department of Veterinary Medicine, College of Veterinary Medicine, Gyeongsang National University
**Department of Pharmacy, College of Pharmacy, Gyeongsang National University
***Advanced Biopharmaceutical Policy TF, Biopharmaceuticals and Herbal Medicine Bureau, Ministry of Food and Drug Safety
**Department of Pharmacy, College of Pharmacy, Gyeongsang National University
***Advanced Biopharmaceutical Policy TF, Biopharmaceuticals and Herbal Medicine Bureau, Ministry of Food and Drug Safety
Correspondence to: #Hye Jin Cha, Department of Veterinary Medicine, College of Veterinary Medicine, Gyeongsang National University, 501 Jinjudaero, Jinju 52828, Korea
Tel: +82-55-772-2376
E-mail: chahj@gnu.ac.kr
Tel: +82-55-772-2376
E-mail: chahj@gnu.ac.kr
Received January 19, 2024; Revised October 28, 2024; Accepted November 13, 2024.
- Abstract
- 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 cross-contamination 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.
- Keywords : Xenotransplantation product, GMP, Source animal, Cross contamination, Genetically modified organism
- December 2024, 68 (6)
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Funding Information-
- Ministry of Food and Drug Safety
10.13039/501100003569
