药品抽检的监督管理和信息公开要求新旧对比研究

Comparative Research Between the New and Old Rules of Drug Supervision and Information Disclosure in the Drug Sampling and Testing Regulations

关键词:  药品抽查检验  监督管理  信息公开  对比研究

Key words:  drug sampling and testing  supervision  information disclosure  comparative research

摘要:

目的 对2019年8月颁布的《药品质量抽查检验管理办法》中监督管理和信息公开方面的新要求进行解读，为相关工作提供参考。方法 对比研究2019年8月颁布的《药品质量抽查检验管理办法》和2006年7月颁布的《药品质量抽查检验管理规定》中监督管理和信息公开相关内容，分析新要求的必要性及意义，并提出实施建议。结果 《药品质量抽查检验管理办法》在监督管理方面新增了追溯不合格药品来源、风险研判及处理、流通环节处罚、工作督促指导、生产经营和使用单位的义务和责任等要求，在信息公开方面新增了公开内容、重大影响研判、信息化管理等要求。结论 新增的要求有利于加强假劣药品和潜在风险的控制处置，改进抽检结果信息公开，应得到药监部门的重视并落实到位。

Abstract:

OBJECTIVE To explain the new rules for drug supervision and information disclosure in the drug sampling and testing regulation which was published in August 2019, and provide a reference for the relevant work. METHODS Compared the drug supervision and information disclosure rules between the regulations issued in August 2019 and July 2006 respectively, analyzed the need and value of the new rules and propose suggestions for implementation. RESULTS The drug sampling and testing regulation issued in August 2019 had added rules on tracing the sources of substandard drugs, research and disposal of risk, penalties of circulation, supervision and guidance of work and obligations and responsibilities of production and circulation units in terms of supervision, and rules on disclosure contents, major impact research and information management in terms of information disclosure. CONCLUSION These new rules facilitate the control and disposal of the counterfeit and inferior drugs and potential risk, and the disclosure of the sampling and testing results. They shall be paid enough attention and implemented in place by the drug supervision departments.