Abstract: Drug safety is closely related to the life and health of the public. With the rapid development of the pharmaceutical industry, drug disputes, drug quality problems, and drug-related harm incidents are becoming increasingly frequent. However, China has not yet incorporated drug forensic appraisal into the scope of forensic appraisal. Against this background, it is urgent for China to establish a sound drug forensic appraisal system. The inspection and identification of drug quality are also key to determination and sentencing of drug-related illegal and criminal acts, and forensic appraisal can also provide relief for parties’ rights in drug quality cases. Starting with a background analysis and taking the Pharmacopoeia of the People’s Republic of China as the main framework, this study analyzes the prominent difficulties in constructing China’s drug forensic appraisal system, with a view to providing a useful reference for the construction of such a system in 

Key words: drug forensic appraisal, drug safety, right relief

摘要： 药品安全关系着公众的生命健康安全，随着医药行业的快速发展，药品纠纷、药品质量问题与药害事件日益增多，然而我国却尚未将药品司法鉴定纳入司法鉴定范畴。基于此，我国亟待构建完善的药品司法鉴定体系。药品质量的检验鉴定也是涉药类违法犯罪行为认定和量刑的关键，同时，还可通过司法鉴定实现当事人在药品质量案件中的权利救济。从背景分析入手，以《中华人民共和国药典》为主线，剖析我国构建药品司法鉴定体系存在的突出难点，以期为我国药品司法鉴定体系的构建提供有益参考。

关键词: 药品司法鉴定, 药品安全, 权利救济