Zhang Li, Wong Lisa Y L, He Ying, Wong Ian C K
Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China.
Drug Saf. 2014 Oct;37(10):765-70. doi: 10.1007/s40264-014-0222-3.
With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.
随着全球制药经济的整合以及中国医疗保险制度的逐步转型，中国国家食品药品监督管理总局（CFDA）已建立了一个全面监管体系的立法框架，以监测包括药物研发、生产、流通和使用在内的全过程，确保用药的安全性和有效性。从1989年到2014年，中国建立了一个相对全面的药物警戒系统，涵盖监管、组织和技术等方面。截至2013年，四级药物警戒网络（国家、省、市、县）包括1个国家中心、34个省级中心和400多个市级药品不良反应（ADR）监测中心，基层组织用户超过20万。中国药品不良反应监测系统（CADRMS）是一个连接四级药物警戒网络的在线自发报告系统。到2013年，CADRMS已收到超过660万份ADR病例报告。在整合和分析药物警戒数据后，国家药品不良反应监测中心（NCADRM）通过发布ADR公告、《国家药品不良反应年度报告》和《国际药物警戒通讯》来公布用药安全信息。NCADRM还定期向制造商提供CADRMS数据反馈。CFDA通过多种方式实施风险管理，包括安排“制造商沟通会议”、修改药品说明书以及限制、暂停或撤销上市许可。与海外监管机构和组织进行无缝信息交流仍是一个有待改进的领域。中国药物警戒系统在信号生成、上市后药物流行病学研究和教育方面也需要进一步发展。
