我国特定药物生物等效性研究技术指导原则汇总及思考

China specific drugs bioequivalence technical guidance summary and consideration

生物等效性试验是评价仿制药与原研药质量和疗效一致性的重要方法,试验方法的科学性、评价标准的适用性、数据资料的规范性直接影响对仿制药质量和疗效评价的准确性。对中国2020年8月以来累计发布的48个特定药物生物等效性研究技术指导原则(含征求意见稿16个)进行逐个汇总、梳理,从多个维度对已发布的特定药物生物等效性研究技术指导原则的发布情况进行概括,结合美国、欧盟及日本等国际先进监管机构相关工作经验,对中国特定药物生物等效性研究技术指导原则的发布情况提出一般考虑,以期提高仿制药质量和疗效,进一步满足临床需求的同时减轻患者用药负担。

Bioequivalence is an important method to evaluate the consistency of quality and efficacy between generic drug and original drug.The scientificity of test method,applicability of evaluation criteria and standardization of data directly affect the evaluation accuracy of generic drug.In this paper,48 technical guidelines for bioequivalence of specific drugs(including 16 draft for comment)released since August 2020 in China were summarized and sorted,and guidelines for bioequivalence research of specific drugs have been summarized from multiple dimensions.Combined with the relevant experience of international advanced regulatory agencies such as United States,European Union and Japan,in order to improve the quality and efficacy of generic drugs in China,further meet the clinical require of patients and reduce the burden of medication,general considerations were put forward for China bioequivalence guidelines of specific drugs.