Regulations and Guidelines Should Be Strengthened Urgently for Re-evaluation on Post-marketing Medicines in China  

作　　者：谢雁鸣 田峰 

机构地区：[1]Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences

出　　处：《Chinese Journal of Integrative Medicine》2013年第7期483-487,共5页中国结合医学杂志（英文版）

基　　金：Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicines,the Ministry of Science and Technology(No.2009ZX09502-030);the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No. Z0215)

摘　　要：This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.

关 键 词：post-marketing medicines RE-EVALUATION regulations and guidelines PHARMACOVIGILANCE 

分 类 号：F203[经济管理—国民经济] F426.72