03 August2020
EMA/409815/2020
Questionsand answersformarketing authorisation holders/applicantsontheCHMPOpinionforthe Article5(3) of Regulation(EC)No726/2004 referralonnitrosamineimpuritiesinhuman medicinal products
人药中亚硝胺杂质
欧盟法规（EC）No726/2004第5（3）条转引CHMP意见
上市许可持有人/申报人问答
Table of contents目录
Introduction概述
1. Should the risk of presence of nitrosamines be considered for all human medicinal products?是否要考虑所有人药中出现亚硝胺的风险？
2. What is the ‘call for review’?什么是“审核要求”？
3. For the ‘call for review’ for chemically synthesised and biological medicinal products, when and how should MAHs report steps 1 and 2 to competent authorities?关于化学合成和生物药品的“审核要求”，MAH应在何时如何向药监当局报告第1步和第2步？
4. What are the currently identified root causes for presence of nitrosamines?目前已识别出的出现亚硝胺的根本原因有哪些？
5. What to do if after completing step 1 and /or step 2 new information (e.g. related to a new potential root causes) is identified?如果完成了第1步和/或第2步之后，又找到了新的资料，应该怎么办（例如，与新的可能根本原因有关）？
6. What factors should be considered in prioritising the risk evaluation?在风险评估优先排序时应考虑哪些因素？
7. How should the risk evaluation be performed?应如何对风险进行评估？
8. How should confirmatory tests be conducted by MAHs and manufacturers? MAH和生产商应如何执行确认性检测？
9. What are the requirements of the analytical method(s)?分析方法有什么要求？
10. Which limits apply for nitrosamines in medicinal products?制剂中的亚硝胺适用哪种限度？
11. What should I do if a nitrosamine is detected in my medicinal product?如果在我的制剂中检出亚硝胺，该如何做？
12. Which are the measures to mitigate the risk of presence of nitrosamines?亚硝胺风险有什么缓解措施？
13. Which changes would be required for Marketing Authorisations?上市许可要求进行什么变更？
14. What is the approach for new and ongoing marketing authorisation applications (MAA)?新的和正在审评的上市许可申报（MAA）处理方法是怎样的？
15. When should a test for nitrosamines be included in the MA dossier?什么时候需要在MA文档中包括亚硝胺检测？
16. What are the responsibilities of MAHs for APIs with CEPs or ASMFs? MAH对具有CEP或ASMF的API负有什么责任？
17. How does the lessons learnt exercise from presence of nitrosaminesin sartans relate to the Article 5(3) Referral Outcome?沙坦类药品中亚硝胺杂质的第5（3）款转引评估结果的教训总结是怎样的？
18. What about regulatory requirements in other regions?其它地区的监管要求是怎样的？
原文官网下载
https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders/applicants-chmp-opinion-article-53-regulation-ec-no-726/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf
文件下载：
2004-referral-nitrosamine-impurities-human-medicinal-product
文章来源：Julia法规翻译
