本课程教学目的是使学生了解我国药事法规体系建设历史和现状,认识建设药事法规体系的必要性;熟悉药品、新药等有关药事管理的基本概念；了解SFDA、FDA、WHO等国内外和国际药事组织的机构和职能；掌握《中华人民共和国药品管理法》、《药品注册管理办法》等法规的主要内容；了解药物知识产权保护相关组织和法规。

This course will make students to understand the importance of setting up pharmaceutical law and regualtions in China. It will also let students to know main organizations related to pharmaceutical affair, such as SFDA, FDA, WHO, ICH etc.. Basic concepts related to Pharmaceutical law and regulation are introduced in this course. The contents of "Drug Administration Law of the People's Republic of China " and "Guidance for Drug Registration(2007)" will be introduced in detail in this course. It will also provide information on intellectual property of drug product.