美国食品药品管理局于2015年10月发布了“改变剂型和改变给药途径药品非临床安全性评价指导原则”,包括前言、背景、一般原则、对全身毒性的建议和对给药途径的建议5个部分,并且分别描述了15种不同给药途径的药品在改变剂型时应增加的非临床毒性研究内容。我国目前尚无这类指导原则,了解该指导原则对我国完善相应法规和制定相应的指导原则及其对这类药物的审评有所启迪,也对改变剂型类药物的开发有所帮助,所以介绍该指导原则的主要内容。

FDA issued “Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route Guidance” in October 2015, including introduction, background, general considerations, systemic toxicity consideration, route of administration considerations, and describing the additional nonclinical toxicity studies for reformulated drug products used in 15 different routes respectively. And there is no such guidance in our country at present. Because understanding the guidance for our country to improve the relevant regulations, to formulate corresponding guidance and to review these drug products are helpful, and for the development of these drug products also is helpful, therefore the main content is introduced.