安全药理学作为一门基于药理学、毒理学和生理学发展而来的新兴学科分支,越来越受到政府药品监管部门和学术界研究者的重视。欧盟相关组织在早期就开展了较为全面的安全药理学研究和标准制定工作。通过对中国和欧盟的新药安全药理学评价指导原则的介绍、分析,比较,阐述了中国与欧盟在临床前安全药理学研究内容、方法以及提交资料方面的差异,为新药研发的临床前安全性评价提供参考并为法律性规范起到借鉴和指引的作用。 As a branch of emerging science based on the development of pharmacology, toxicology and physiology, safety pharmacology has drawn more and more attention from government drug regulatory authorities and academic researchers. Related organizations in the EU carried out a relatively comprehensive safety pharmacology research and standard setting work early. Through the introduction of guiding principles for the evaluation of new drug safety pharmacology in China and the EU, the differences and differences in the contents, methods and submissions of preclinical safety pharmacology between China and the EU have been analyzed and compared to provide a reference for the preclinical safety of new drug research and development Evaluation provides a reference and legal norms play a role in reference and guidance.