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| 英国2018年GMP检查缺陷对中国GMP实施的启示 |
| Statistical Analysis and Implications of Drug GMP Inspection deficiency in 2018 Among NMPA, Shanghai region and MHRA |
| 投稿时间：2020-04-23 修订日期：2020-07-31 |
| DOI： |
| 中文关键词: NMPA HMRA 质量体系 符合性 有效性 数据可靠性 |
| 英文关键词: NMPA HMRA Quality Management System Compliance Effectiveness Data Integrity |
| 基金项目:上海市科学技术委员会软科学研究项目（药品上市许可持有人制度下的长三角区域协作药品监管制度与策略研究，19692106300） |
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| 中文摘要: |
| 目的 药品检查的缺陷情况及其变化趋势，不仅反应行业整体发展水平的衍化，也凸显出不同监管当局监管理念、监管焦点的变化；本文通过对比国内外检查缺陷及其变化趋势，以获得对中国GMP实施的建议。方法 对比英国HMRA、中国NMPA及上海地区药品GMP检查缺陷，分析GMP检查的发展趋势，阐述对国内药品监管和企业管理的启示。 结果与结论 对政府监管和企业管理的启示：一是检查重点由“检验”回归到“体系”，二是由关注“有没有”（符合性）到“有没有效”（有效性），三是确保落实企业主体责任、完善自检管理体系，四是持续关注数据可靠性。 |
| 英文摘要: |
| Objective：The deficiencies in drug inspection and its changing trend not only reflect the evolution of the overall development level of the pharmaceuticals?industry?,but also reflect the changes in the regulatory concept and focus of different regulatory authorities.This paper compares the deficiencies and their changing trends at home and abroad in order to get Suggestions on the implementation of GMP in China. Methods: the deficiencies of drug GMP inspection in HMRA, NMPA and Shanghai district were compared, the development trend of GMP inspection was analyzed, and the enlightenment to domestic drug supervision and enterprise management was expounded.?Results and Conclusion:Implications for government regulation and pharmaceutical management: first, the focus of inspection should return from "inspection" to "system"; second, it should focus on "whether" (compliance) to "whether" (effectiveness); third, it should ensure the implementation of the main responsibility of drug manufacturers and improve the self-inspection management system; fourth, it should continue to pay attention to data integrity. |
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