Abstract:Gene-edited pig xenotransplantation, as a potential solution to the global organ shortage crisis, has achieved a series of breakthroughs from animal experiments to clinical exploration. This groundbreaking technology that transcends species boundaries poses a serious challenge to the traditional ethical review model, which is based on separate systems of human ethics, organ transplantation ethics, and animal ethics. It reveals the systemic deficiencies such as inconsistent review standards, unclear rights and responsibilities, and incomplete scope in the current system. This article aims to base its discussion on the latest regulations issued by the State Council, namely the "Regulations on Clinical Research and Clinical Transformation Application of Biomedical New Technologies", and explore how to establish an integrated ethical review system specifically applicable to xenogeneic organ transplantation. Through a systematic analysis of the entire process management, the legalization of review subject qualifications, and the filing and assessment mechanisms stipulated in the "Regulations", it demonstrates that these measures provide a crucial institutional opportunity to bridge the gaps in the existing ethical review system. This article deeply identifies the core ethical issues specific to xenogeneic transplantation, such as the complexity of informed consent, public risks in biological safety, and the rising moral status of animals. Based on this, it proposes specific measures for the construction of an integrated review system. It is believed that with the "Regulations" as the guideline, promoting the deep integration and institutional connection of medical ethics, organ transplantation ethics, and experimental animal ethics is the key to ensuring the safe, orderly, and ethical development of xenogeneic organ transplantation technology. It also has significant theoretical and practical significance for leading the ethical governance of frontier biotechnology.