论文部分内容阅读
本文了简述在美国有关OTC药品的法规、分类；OTC药品与注册技术要求和审评过程以及专家咨询小组的职责。同时也介绍了在美国处方药改为OTC药品的原则。
This article outlines the statutes and classifications of OTC drugs in the United States; the technical requirements and review process for OTC drugs and registrations; and the responsibilities of the expert advisory group. It also introduced the principle of changing prescription drugs to OTC drugs in the United States.