| 董谦,田蒙,孟芸,余新华.日本组合医疗产品监管政策研究[J].中国药事,2022,36(10):1198-1202 |
| 日本组合医疗产品监管政策研究 |
| Research on Supervision Policies of Japanese Medical Combination Products |
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| DOI：10.16153/j.1002-7777.2022.10.012 |
| 中文关键词: 组合医疗产品 药械组合产品 药品 医疗器械 监管政策 |
| 英文关键词: combination products drug-device combination products drugs medical devices supervision policies |
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| 中文摘要: |
| 目的： 通过对日本组合医疗产品全生命周期监管有关政策的研究，思考药械组合产品监管应关注的重点问题，以期科学把控风险、落实有效监管。方法：系统介绍日本医药品及医疗器械综合管理机构发布相应管理文件的核心内容，并结合美国、中国的相关政策情况对比分析。结果与结论：可从细化监管政策、做好风险评估和加强国际协调三方面借鉴相关经验，以促进我国药械组合产品行业的创新发展。 |
| 英文摘要: |
| Objective: Through the research on the policies of the whole life cycle supervision of Japanese medical combination products, the key issues about the supervision of drug-device combination products should be paid attention to in order to scientifi cally control risks and implement eff ective supervision. Methods: The core content of the corresponding management documents issued by the Pharmaceuticals and Medical Devices Agency in Japan was systematically introduced, and a comparative analysis of the relevant policies in the United States and China was carried out. Results and Conclusion: In order to promote the innovation and development of drugdevice combination product industry in China, relevant experiences in three aspects could be used for references, including refining regulatory policies, carrying out the risk management well and strengthening international coordination. |
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