目的 为业内人士更好的理解和执行2020年版《中国药典》四部生物检定相关内容提供帮助。方法 笔者介绍了2020年版《中国药典》四部生物检定相关标准的形成机制和增修订概况,梳理汇总了主要特点和增修订内容,并简要阐述了下一步的工作展望。结果与结论 2020年版《中国药典》四部生物检定相关内容的增修订工作进一步健全了药典中涉及安全性和有效性评价的标准体系,也将继续加强安全性控制方法的建立完善,以保障公共用药安全,服务药品监管。

OBJECTIVE To provide help for better understanding and implementation of the biologic tests and assays in the Chinese Pharmacopoeia (Ch.P) 2020 Edition Volume Ⅳ. METHODS This paper introduces the formation mechanism of the relevant standards and the general situation of the addition and revision, summarizes the main features and the contents of the revision, and briefly describes the work prospect in the next step. RESULTS AND CONCLUSION The revision of the biologic tests and assays in the Ch.P 2020 Edition Volume Ⅳ further improves the standard system of safety and effectiveness evaluation. Safety control methods will be also further established to ensure the safety of public drug use and serve drug supervision.