【摘要】 非临床研究是评价新药有效性和安全性必不可少的环节，但是超过90%的候选药物在进入临床研究后遭遇失败，其中一个主要原因在于非临床阶段的二维细胞模型及动物模型的局限性，无法准确预测药物在人体内的作用。近年来各类新技术不断涌现，其中类器官和器官芯片等仿生技术因其能够模拟人体器官的部分或关键功能，为解决该问题提供了新的技术，逐渐应用于新药评价中。但如何评价和验证类器官模型的可靠性、科学性和适用性，推动其在新药评价中的应用，是目前国内外监管机构面临的监管科学难题和挑战。本文介绍了类器官和器官芯片的技术进展及其在新药评价中的典型应用，分析了国内外相关药品监管机构的政策法规和监管行动，以促进此类新技术在新药评价中的应用，并为其行业标准制定及监管科学发展提供参考和指导。更多还原

【Abstract】 Non-clinical research is an essential link in evaluating the efficacy and safety of new drugs, but more than 90% of candidate drugs fail after entering clinical trials, one of the main reasons lies in the limitations of two-dimensional cell and animal models in the non-clinical stage, which are unable to predict the effects of drugs in the human body accurately. In recent years, various new technologies have emerged, among which biomimetic technologies such as organoids and organ-on-chips provide new technologies to address this issue because they can mimic some or key functions of human organs and are gradually applied in evaluating new drugs. However, how to evaluate and verify the organoid models’ reliability, scientificity, and applicability and promote their applications in new drug evaluation is still a difficult problem and challenge in regulatory science faced by domestic and foreign regulators at present. This paper introduced the technical progress of organoids and organ-on-chips and their typical applications in new drug evaluation, and analyzed the policies, regulations, and regulatory actions of relevant drug regulatory agencies at home and abroad, with a view to promoting the application of such new technologies in the evaluation of new drugs and providing reference and guidance for the formulation of its industry standards and the development of regulatory science.更多还原