小结（Summary）

本章回顾了中国药品监管系统的发展过程、药物警戒相关法规在中国的发展和中国的药物监管体系逐步走向国际化的历史变迁。相比《药物临床试验质量管理规范》（GCP），药物警戒在国内起步较晚，以仿制药为主的医药市场，药品上市后的药物警戒重点多是由药品质量问题引起的不良反应和药害事件，对监测到的信号的分析和对风险的管理尚在探索和完善中。伴随中国药品监督管理机构正式加入ICH以及ICH指导原则在中国的落地实施、新药审评审批制度的改革带来的新药在国内更快的上市和批准，以及上市许可持有人（MAH）制度的试点运行和即将到来的这一制度的全面推进，对药品全生命周期的监管，尤其是上市前的风险评估和管理受到了高度重视，这些都将极大地促进对药物警戒概念的正确和深入理解，有益于中国全面参与全球统一的公共卫生工作以及生物制药创新，为药物开发和药物警戒塑造未来的技术和政策环境。

This chapter has reviewed the development of pharmacovigilance regulations and practice in China's drug regulatory system.Pharmacovigilance requirements and regulations in China were lagged considerably behind the requirement for Good Clinical Practice（GCP）.Pharmacovigilance activities in China previously focused more on the monitoring of adverse events associated with product quality issues but a systemic approach and regulatory framework for signal detection，evaluation and risk management was not well established.With the Chinese health authority joining in the ICH and the implementation of ICH guidelines，China has adopted a fasttrack approach in its drug evaluation and approval system，allowing more new and innovative drug to be on the market.Additionally，the pilot program and upcoming implementation of marketing authorisation holder（MAH）system will be emphasized and re-enforced the role and responsibility of MAHs across product life cycle，including the risk evaluation and management activities at both pre-approval and post-approval stages.Pharmacovigilance knowledge and experience in China will be greatly enriched，which will be beneficial to China for participating in the global public health and drug development activities，and will also help create a supportive regulatory environment for drug innovation and pharmacovigilance in China.A joint effort from government，industry，academic institutions，hospitals and public is required for the establishment of a comprehensive pharmacovigilance system with risk management concepts across product life cycle and to ensure safe use of the medicinal products.

（唐 雪 高 杲）