期刊文献+

中国疫苗安全监管现状、问题及对策 被引量:33

Supervision,problems and countermeasures on vaccine safety in China
原文传递
导出
摘要 疫苗安全关乎公众健康,关乎卫生事业的发展,关乎社会的稳定。本文结合近几年出现的疫苗事件,简要分析了中国疫苗安全研发、审批、生产、流通、接种等环节的监管现状,指出当前疫苗安全在各个环节监管上存在的问题,并结合2016年新版《疫苗流通和预防接种管理条例》的实施,针对疫苗监管的现存问题,提出了一些对策与建议,其中包括鼓励发展医药冷链物流、健全疫苗补偿机制和召回制度、完善不良反应监测系统、健全疫苗法律法规、加强相关监管部门间的协作和对接种人群普及疫苗知识等。 Vaccine safety is very important to public health, the development of health service and the stability of the society. Combining with the vaccine adverse events in recent years, this article briefly analyzes the current supervision status of research, approval, production, circulation and utilization concerning vaccine safety, points out problems of the current vaccine safety in each link. Based on the implementation of 2016 new edition Vaccine Circulation and Vaccination Management Regulations,this article puts forward some countermeasures and suggestions to solve the existing problems of our country's vaccine regulation. These measures include that the government departments should encourage the development of medical cold chain logistics, improve the compensation system of vaccine, complete the traceability system in the whole link, supply the adverse drug reactions monitoring system, improve the vaccine laws and regulations, strengthen the supervision and collaboration of relevant departments and popularize the knowledge of vaccine to the public, etc.
出处 《中国公共卫生管理》 2017年第2期192-195,共4页 Chinese Journal of Public Health Management
关键词 疫苗 安全 监管 问题 对策 vaccine safety supervision problems countermeasures
  • 相关文献

参考文献11

二级参考文献57

  • 1黎青松,雷西,黎春辉.我国疫苗供应链浅析[J].物流技术,2007,26(2):137-140. 被引量:7
  • 2World Health Organization. WHO Guidelines on Preclinical Evaluation of Vaccines[ S]. 2005.
  • 3国家食品药品监督管理局药品审评中心.预防用生物制品临床前安全性评价技术审评一般原则[S].2005.
  • 4EMEA. Note for Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines[ S]. 1997.
  • 5FDA. Workshop on non-clinical safety evaluation of preventive vaccines: recent advances and regulatory considerations[ S]. 2002.
  • 6BALA S, WEAVER J, HASTINGS K. Clinical relevance of preclinical testing for allergic side effects[ J ]. Toxicology, 2005, 209 (2) : 195 -200.
  • 7FDA. Considerations for reproductive toxicity studies for preventive vaccines for infectious disease indications(Draft) [ S]. 2000.
  • 8VERDIER F, MORGAN L. Predictive value of pre-clinical work for vaccine safety assessment[ J ]. Vaccine, 2002, 20 ( Suppl 1 ) : S21 -S23.
  • 9[1]VAERS Continuing Education.Vaccine Safety Post-marketing SurveiUance:The Vaccine Adverse Event Reporting System[EB/OL].Available at http://www.vaers.hss.gov/ce.htm.
  • 10[2]Steven Rosenthal,Robert Chen.The reporting sensitivities of two passive surveillance systems for vaccine adverse events[J].Am J Pub Health.1995,85:1706-1709.

共引文献84

同被引文献278

引证文献33

二级引证文献120

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部