ABSTRACT
OBJECTIVE：To learn from the experie nce of post-marketing risk management of biopharmaceuticals in the United States，and to provide reference for post-marketing risk management of biopharmaceuticals in China. METHODS ：By studying guidance documents and website information issued by FDA ，the risk management of biopharmaceuticals after marketing in the United States was analyzed. Taking infliximab as an example ，the specific implementation situation was introduced ，the management characteristics were summarized ，and the enlightenment and relevant suggestions were put forward for the risk management of biopharmaceuticals after marketing in China. RESULTS & CONCLUSIONS ：The post-marketing risk management of biopharmaceuticals in the United States mainly includes two aspects as “risk evaluation and mitigation strategy （REMS）”and “post-marketing study and clinical trials system ”. The latter included post-marketing requirement （PMR） and post-marketing commitment（PMC）. Taking infliximab as an example ，since it was approved by FDA in August 1998，its manufacturer submitted REMS to FDA in 2009 and obtained approval ，and proposed post-marketing studies and clinical trials for five times. It can be seen that FDA has issued specific guidelines for post-marketing risk management of biopharmaceuticals to encourage multi-role participation in risk management ， realize effective communication with patients ， and continuously supervise the risk of biopharmaceuticals，so as to reduce the risk of the use of biopharmaceuticals. For biopharmaceuticals ，China has not yet formulated systematic and specific implementation rules and guidelines ，and there is still lack in post-marketing risk management. It is suggested that China can learn from the measures and system of post-marketing risk management of biopharmaceuticals in the United States ，involve stakeholders in post-marketing management ，enhance patients ’awareness of drug use risks through effective communication，and further improve the post-marketing research management system to guarantee patients ’safety of drug use.