EMA 用于胃肠道局部并作用于局部的仿制药或改剂型药的治.PDFVIP

• 1050 • Drug Evaluation Research 第40 卷 第8 期 2017 年8 月 EMA 用于胃肠道局部并作用于局部的仿制药或改剂型药的治疗等效性 研究指导原则介绍 萧惠来 国家食品药品监督管理总局 药品审评中心，北京 100038 摘 要：欧洲药品局（EMA ）于2017 年3 月公布了“证明用于局部并在胃肠道局部起作用的产品治疗等效性的等效性研究 指导原则（草案）”，提出了对这类等效性研究的一般要求，详细地介绍了对作用于口腔和（或）咽喉、胃、肠道以及直肠等 胃肠道不同部位的药物等效性研究的要求，重点介绍了临床试验替代方法–体外等效性试验和药动学生物等效性研究。介绍 该指导原则主要内容，期望对我国这类仿制药和改剂型药疗效一致性评价思路和方法有启发。 关键词：欧洲药品局；胃肠道局部作用；仿制药；等效性；指导原则 中图分类号：R945.2 文献标志码：A 文章编号：1674-6376 (2017) 08- 1050 -09 DOI: 10.7501/j.issn.1674-6376.2017.08.003 Introduction to EMA guideline on therapeutic equivalence studies of generic and reformulated products that are locally applied, locally acting in gastrointestinal tract XIAO Hui-lai Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China Abstract: EMA announced Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents (Draft) in March 2017, and proposed the general requirements for this equivalence study, introduced the requirements of equivalence studies for drugs acting different parts of the gastrointestinal tract, such as the mouth and/or throat, stomach, intestine and rectum, in detail, which focus on alternative methods of clinical trials －in vitro equivalence tests and PK bioequivalence studies. The guideline is introduced and it is expected to enlighten the trains of thought and methods for efficacy consistency evaluation of such generic and reformulated products in China. Key words: EMA; locally acting in the gastrointestinal tract; generic; equivalence; guideline 欧洲药品局（EMA ）于2017 年3 月发布了“证 1 前言 明用于局部并在胃肠道局部起作用的产品治疗等 该指导原则适用于局部给药并拟在胃肠（GI ） 效性的等效性研究指导原则——作为用于局部并 道局部