FDA“简化新药申请的透皮和局部给药系统黏附性评估的供企业用指导原则草案”介绍

Introduction to FDA's Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry

美国食品药品管理局(FDA)于2023年4月发布了“简化新药申请的透皮和局部给药系统(TDS)黏附性评估的供企业用指导原则草案”,修订了2018年公布的同名指导原则草案。该修订的指导原则草案包括前言、背景、黏附性的评价、黏附性和生物等效性的综合评价以及数据提交格式5部分。重点讨论了仿制TDS黏附性的临床评价,包括其研究设计和实施以及统计分析。中国目前还没有类似的指导原则,详细介绍FDA的该指导原则草案,期望对我国仿制的TDS的黏附性评估的临床研究和药品监管部门的审评有帮助。

The US Food and Drug Administration(FDA)released Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry in April 2023.This draft guidance revised the draft guidance with the same name published in 2018.The revised draft guidance include five parts:introduction,background,evaluation of adhesion,combined evaluation of adhesion and bioequivalence,and format of data submission.The focus was on the clinical evaluation of the adhesion of generic TDS,including its study design and conduct,as well as statistical analysis.At present,there is no similar guidance in China.This article provides a detailed introduction to the FDA's draft guidance,hoping to be helpful for clinical research and review by drug regulatory authorities on the adhesion evaluation of generic TDS in China.