药物警戒的相关指导原则和法规体系是伴随着对药物安全的深入认识而逐步发展和完善的。20世纪60年代的“反应停”事件使人们认识到,上市前的有限的临床研究不足以全面揭示药品风险,药品安全问题只有在大范围人群的临床应用中才能发现。基于此认识,世界各国相继建立了药物不良反应监测制度,这使建立国际统一标准成为了实际需要。在多个重要国际组织、多个国家和地区的药品管理部门的共同努力下,药物警戒的法规体系逐步 Pharmacovigilance guidelines and regulatory system is accompanied by a deep understanding of drug safety and gradually develop and improve. The ’reaction to’ events of the 1960s led to the recognition that limited clinical studies prior to listing are not enough to fully reveal the risks of drugs and that drug safety issues can only be detected in clinical applications in a wide range of populations. Based on this understanding, all countries in the world have successively set up drug adverse reaction monitoring system, which has made it an actual need to establish a standard of international harmonization. With the joint efforts of a number of major international organizations and drug regulatory agencies in many countries and regions, the drug regulatory system has gradually been phased out