关键词: 药品生产企业, 药物警戒, 警戒体系

Abstract: Objective Through discussing the necessity and factors of drug manufacturers' pharmacovigilance(PV) system, to provide reference and help in building and improving their pharmacovigilance system. Methods By referring the four elements of "human resource, machine, material, law and process" in quality management theory, the drug manufacturers are proposed on how to set up the pharmacovigilance system, at least they should have full-time staff and PV function, enough safety information collection, comprehensive and practical quality management system of documentation, efficient data processing system, and enterprise environment full of "patient safety first". Results and Conclusion With the development of science and technology of society and the continuous improvement of people's living quality requirements, the problem of drug safety are getting more and more attention from us. Drug manufacturers should strengthen their works to commit "the primary responsibility of drug safety" actively. They should strengthen their cognition and understanding of the pharmacovigilance, and establish the Quality Management System, set up PV specific function and full-time personnel to be responsible for the ADR monitoring work, and at the same time increase their internal PV training to establish an efficient PV system and ultimately provide the necessary guarantee for the development of the pharmacovigilance work.

Key words: drug manufacturer, pharmacovigilance, pharmacovigilance system