美国FDA生物等效性指导原则的修订与仿制药一致性评价

目的介绍中国药学会翻译的美国FDA《特定药物的生物等效性指导原则》中涉及289目录的185个品种,从2016年6月至今的BE试验指导原则的更新情况,作为对已发布的中文翻译稿的补充。方法在FDA网站上对相关品种逐一进行检索,研究和分析有修订的10个品种和新增的2个品种的BE试验指导原则发生更新的可能原因。结果与结论美国FDA《特定药物的生物等效性指导原则》一直处于持续更新状态。在我国开展仿制药质量与疗效一致性评价的工作中,业内人士应密切关注其更新情况,及时获得最有价值的参考信息。

Revision of U. S. FDA bioequivalence guidelines for specific products and consistency evaluation of generic drugs

Objective To introduce updated versions of U. S. FDA Guidance for Industry Bioequivalence Recommendations for Specific Products including 185 products in 289 varieties from June 2016 till now, as supplements to the released Chinese versions translated by Chinese Pharmaceutical Association. Methods The related varieties were searched one by one on the FDA website, and the possible reasons for ten updated varieties and two new varieties of bioequivalence guidelines were studied and analyzed. Results and Conclusion U. S. FDA Guidance for Industry Bioequivalence Recommendations for Specific Products has been continuously updated. It should be paid close attention to the latest revision in the quality and effect consistency evaluation of generic drugs in China, and thus the most valuable reference information would be obtained in