摘要
目的:为建立我国药品上市后再评价制度提供参考,保证药品上市后的安全、有效。方法:收集并介绍美国、日本及世界卫生组织药品上市后再评价的相关法律、制度。结果与结论:美国、日本及世界卫生组织均对药品上市后再评价制订了相关法律及制度,还有具体的实施规范和技术支撑计划,值得我们借鉴。
Objective: To provide the references for policymaking on post-marketing drug reevaluation in China, and to improve the post-marketing rational use of drugs. Methods: The relevant laws and institutions about postmarketing drug reevaluation made by the U.S. Japan and the World Health Organization were collected and introduced. Results and Conclusion: Laws with the specific code of practice and technology were established to guarantee the post-marketing drug reevaluation in the U.S. Japan and WHO, which could provid the references to ensure the safety and rational use of drugs in our country.
出处
《中国药事》
CAS
2016年第4期406-410,共5页
Chinese Pharmaceutical Affairs