制药企业药品上市后风险管理政府监管效果影响因素研究

The Research of the Influence Factors of Government Regulation for the Drug Post-Marketing Risk of Enterprises

目的药品的安全监管是贯穿于药品的整个生命周期的,目前对生产企业药品上市后风险管理的政府监管存在不足。政府监管效果影响因素的研究可为药品上市后风险政府监管措施提供背景参考。方法笔者通过文献研究与专家咨询法分析生产企业药品上市后风险政府监管效果的影响因素,并对影响因素指标进行分析。结果从分析统计结果来看,监管相关的法律和法规以及监管结果的发布是监管效果影响的最重要的因素。结论应进一步完善药品上市后监管的法律法规,对监管结果的公开形式和内容进行科学规划。

OBJECTIVE Drug safety regulation is throughout the entire life cycle of drugs. However, the government regulation for the drug post-marketing risk of enterprises have some shortcomings. The research of the impacting factors of government regulation can provide some background reference for the drug post-marketing risk regulation. METHODS In this paper, the influence factors of government regulation for the drug post-marketing risk of enterprises was analyzed by literature research and Delphi method. RESULTS From the analysis results, the regulation related laws and regulations and the outcome of regulation is the most important factor. CONCLUSION It should be further improved the laws and regulations of the drug post-marketing regulations, and the regulation outcome and form should be planned.