欧美已批药品生产变更研究

发布时间：2018-05-16 02:01

本文选题：药品生产变更 + 以风险为基础　；参考：《中国药物警戒》2016年08期

【摘要】：目的为完善我国已批药品生产变更提供建议。方法研究欧美基于风险级别的方法监管已批药品上市后的变更规定,并分析我国现行变更管理体系中存在的问题。结果欧美采取以风险为基础划分变更事项风险级别的方法,加强对高风险生产变更的监管,合理配置监管资源;并在划分风险级别的基础上应用上市后变更管理方案,增加企业对生产变更操作的灵活性和对上市后变更的预测性,增强企业对产品和生产工艺的理解,促进企业应用新技术,节约监管资源和企业变更成本。结论我国应改变统一的生产变更监管方式,采取以风险为基础的监管方式,并采用上市后变更管理方案,增加企业生产变更操作的灵活性,促进企业持续改进和创新药品生产工艺,减轻企业和监管机构的负担。
[Abstract]:Objective to provide suggestions for the improvement of the changes in the production of approved drugs in China. Methods the methods based on risk level in Europe and the United States were studied to supervise the changes in the approved drugs and the problems in the current change management system in China were analyzed. Results Europe and America adopted the method of dividing the risk level of change items based on risk, strengthening the supervision of high-risk production change, allocating supervision resources reasonably, and applying the post-marketing change management scheme on the basis of dividing risk level. It can increase the flexibility of the operation of production change and the predictability of the change after listing, enhance the understanding of product and production process, promote the application of new technology, and save the resources of supervision and the cost of enterprise change. Conclusion China should change the unified mode of supervision of production change, adopt the method of risk-based supervision, and adopt the scheme of change management after listing, so as to increase the flexibility of the operation of production change in enterprises. To promote enterprises to continuously improve and innovate pharmaceutical production processes and lighten the burden on enterprises and regulatory bodies.
【作者单位】：沈阳药科大学工商管理学院;
【分类号】：R954

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