原辅包
English translation: AEP（APIs+ excipients + packaging）
| 07:02 Mar 15, 2024 |
| Chinese to English translations [PRO] Medical - Medical (general) / 医学 | |||||||
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|  Selected response from: Randy Wong China Local time: 21:57 | ||||||
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| 5 | AEP（APIs+ excipients + packaging） |
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Answers
52 mins confidence: 
AEP（APIs+ excipients + packaging） Explanation: 为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），原食品药品监管总局发布了《关于调整原料药、药用辅料和药包材审评审批事项的公告》（2017年第146号），2019年7月16日，国家药品监督管理局发布《关于进一步完善药品关联审评审批和监管工作有关事宜的公告》，就原料药、药用辅料、直接接触药品的包装材料和容器（以下简称原辅包）与药品制剂关联审评审批和监管有关事宜进行了进一步明确。 APIs, pharmaceutical excipients, packagingmaterials and containers in direct contact with pharmaceuticals (hereinafter referred to as AEP: APIs+ excipients + ackaging) with drugs/preparations. 参见： https://www.chinadaily.com.cn/specials/nmpanewsletter201907.... |
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