FDA对复方激素类避孕药说明书的要求

FDA Requirements for Combined Hormonal Contraceptive Labeling

美国食品药品管理局(FDA)于2017年12月发布了"复方激素类避孕药说明书指导原则"。该指导原则对这类药物说明书各个项目提出了详细而具体的要求。介绍该指导原则的主要内容,期待对我国这类药物说明书充实内容、补充重要信息和准确反映目前的科学认识水平有所帮助。

FDA issued the ＂Labeling for Combined Hormonal Contraceptives Guidance for Industry＂ in December 2017. The guidance includes detailed and specific requirements for each section of Combined Hormonal Contraceptives（CHCs） Labeling. This paper introduces the main contents of the guidance, and expects to be helpful to enrich the contents, supplement important information, and accurately reflect the current level of scientific understanding for the Labeling of CHCs in China.