| 张炜敏,黄宝斌,成双红.对比分析4版《生物制品批签发管理办法》探讨我国生物制品批签发管理工作[J].中国药事,2021,35(6):607-613 |
| 对比分析4版《生物制品批签发管理办法》探讨我国生物制品批签发管理工作 |
| On the Management of Lot Release of Biological Products in China under the Comparative Analysis of Four Editions of Management of Lot Release of Biological Products |
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| DOI：10.16153/j.1002-7777.2021.06.001 |
| 中文关键词: 生物制品 批签发 管理办法 管理 |
| 英文关键词: biological products lot release administrative regulations management |
| 基金项目: |
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| 摘要点击次数: 490 |
| 全文下载次数: 10 |
| 中文摘要: |
| 目的：促进相关人员更好地了解生物制品批签发管理发展历程，理解《生物制品批签发管理办法》，落实批签发工作，加强生物制品监管。方法：以4版《生物制品批签发管理办法》为主要研究对象，对比相邻两版内容差异，结合施行中出台的相关政策，梳理分析我国生物制品批签发管理历程、特点和要求。结果与结论：从4版《生物制品批签发管理办法》及相关政策的变化可以看出，在顶层设计和实践总结的基础上，我国生物制品批签发管理制度不断完善。各相关方职责责任日益明确，并越发注重批签发申请人主体责任和基于科学监管的“放管服”改革。在今后的实践中，应坚持问题导向、严格监管、优化服务，不断细化规范批签发工作，依法强化全过程监管和风险控制，与时俱进地服务产业发展和公众需求。 |
| 英文摘要: |
| Objective: To promote a better understanding of the development process of lot release management of biological products, to master the Management of Lot Release of Biological Products in order to implement lot release work and to strengthen the supervision of biological products. Methods: Taking 4 editions of Management of Lot Release of Biological Products as the main research objects, this article compares the content differences between the two adjacent editions and combs and analyzes the development process, characteristics and requirements of the management about lot release of biological products in China by combining the relevant policies issued during the implementation of Management of Lot Release of Biological Products. Results and Conclusion: From the changes of 4 editions of Management of Lot Release of Biological Products and related policies, we can see that, on the basis of top-level design and practice summary, the management system of lot release management of biological products has been continuously improved in China. The responsibilities of all parties concerned are becoming clearer and clearer, and the main body responsibility of the applicants hasincreasingly been emphasized. Based on scientific supervision, the reform to delegate power, improve regulation and upgrade services has been undertaken. The future practice should stick to be problem-oriented, supervise strictly, optimize service, constantly refine and standardize the work of lot release, strengthen the whole process supervision and risk control according to law and keep pace with the service for industrial development and public demand. |
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