| 钱利武,金斌.药品上市许可持有人制度下中药饮片委托生产的可行性分析及建议[J].中国药事,2020,34(11):1314-1319 |
| 药品上市许可持有人制度下中药饮片委托生产的可行性分析及建议 |
| Feasibility Analysis and Suggestions on the Contract Manufacturing of Chinese Herbal Decoction Pieces Under the System of Marketing Authorization Holder |
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| DOI：10.16153/j.1002-7777.2020.11.010 |
| 中文关键词: 药品上市许可持有人 中药饮片 委托生产 |
| 英文关键词: marketing authorization holder Chinese herbal decoction pieces contract manufacturing |
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| 中文摘要: |
| 目的：分析在实施药品上市许可持有人制度下开展中药饮片委托生产的可行性。方法：结合我国现有的药品委托生产相关法律法规，对推行中药饮片委托生产的益处和存在的风险进行分析评估。结果与结论：在风险管控的前提下，中药饮片委托生产有助于优化生产资源配置，降低企业生产和管理成本，改进企业现有的质量管理工作，促进饮片行业的健康有序发展。 |
| 英文摘要: |
| Objective: To analyze the feasibility of contract manufacturing of Chinese herbal decoction pieces under the system of marketing authorization holder. Methods: Based on the existing laws and regulations related to contract manufacturing in China, the advantages and risks of implementing contract manufacturing of Chinese herbal decoction pieces were analyzed and evaluated. Results and Conclusion: Under the premise of risk management and control, the contract manufacturing of Chinese herbal decoction pieces is helpful for enterprises to optimize the allocation of production resources, reduce the production and management costs, improve the quality management, and promote the healthy and orderly development of Chinese herbal decoction pieces industry as well. |
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