| 李香玉,梅妮,陈桂良.美国食品药品监督管理局关于“新兴制药技术”的监管理念与实践[J].中国药事,2020,34(7):836-839 |
| 美国食品药品监督管理局关于“新兴制药技术”的监管理念与实践 |
| The Regulatory Philosophy and Practice of Emerging Pharmaceutical Technologies Issued by US Food and Drug Administration |
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| DOI：10.16153/j.1002-7777.2020.07.017 |
| 中文关键词: 药品 制药 新技术 美国 监管 |
| 英文关键词: drugs pharmaceutical industry emerging technologies the United States regulation |
| 基金项目:国家药典委员会课题“药品质量风险及药品生命周期管理指导原则建立研究”(编号 2008Y001) |
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| 中文摘要: |
| 目的：研究和借鉴美国食品药品监督管理局(FDA)对“新兴制药技术”的监管理念，以促进我国制药业主动迎接新技术挑战，实现创新发展。方法：梳理和分析FDA对“新兴制药技术”的认定、 分类、监管理念、应用考量与实践等。结果与结论：新兴制药技术也将是我国制药业发展的一次重要机遇，监管部门应深入研究并明确监管政策，推动其产业应用。 |
| 英文摘要: |
| Objective: To study and use the experience of the regulatory philosophy of emerging pharmaceutical technologies issued by US Food and Drug Administration so as to facilitate China's pharmaceutical industry in grasping the important opportunity of the application of emerging pharmaceutical technologies. Methods: The definition, classification, regulation concepts, application considerations and practice of emerging pharmaceutical technologies by FDA were reviewed and analyzed. Results and Conclusion: The Emerging Pharmaceutical Technology is also an important opportunity for the development of China's pharmaceutical industry. The regulatory department should make a thorough study, clarify the regulatory policy and promote its industrial application. |
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