仿制药质量一致性评价及有关建议  

Suggestions on quality consistency evaluation for generic drugs

作　　者：黄仲义[1] 李光慧[1] HUANG Zhongyi;LI Guanghui(the GCP Office, the Central Hospital of Jing’an District, Shanghai 200040, China)

机构地区：[1]上海市静安区中心医院药物临床试验办公室,上海200040

出　　处：《上海医药》2019年第7期3-5,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：仿制药与原研药的质量存在差异,美、日等发达国家很早就开始采取提高仿制药质量的管理措施。我国由于历史原因,仿制药质量良莠不齐,而现下要求的一致性评价的目的正在于提高仿制药质量。不过,仿制药质量一致性评价本身也存在局限性,如药学等效性研究中的未知的质量差异、稳定性差异、临床不确定性和生物等效性研究中的时间、样本量限制等。建议在药学等效性研究中进一步包括质量标准和活性成分的晶型、粒度、杂质等主要药学指标的一致性比较,仿制药的稳定性和在临床疗效上的一致性也需有更多的数据来证明。The quality of generic drugs is not necessarily equal to that of the original drugs. Some management measures to improve drug quality have been long adopted in the developed countries such as the United States and Japan. However, the generic drugs in China vary in quality due to the use of different registered standards. The purpose of the ongoing quality consistency evaluation is to improve the quality of domestic generic drugs. Nonetheless, consistency evaluation itself has limitations such as unknown quality differences, stability differences and clinical uncertainty in pharmaceutical equivalence studies, and the limited time and sample size in bioequivalence studies. So, it is recommended to further include consistency evaluation of particular items such as the quality standard, the crystal form and the particle size of the active ingredient and the impurity content in the pharmaceutical equivalence study. And further data are needed to confirm the stability and therapeutic equivalence of the generic drugs.

关 键 词：仿制药 药品质量 一致性评价 

分 类 号：R927.11[医药卫生—药学] R951