翻译： JULIA来源： Julia法规翻译
延伸阅读：
16 July 2018
EMA/CHMP/466973/2018
Timetable for the procedure
Referral under article 31 of Directive 2001/83/EC
依指令2001/83/EC第31条转EMA处置的程序时间表
Valsartan-containing medicinal products
含缬沙坦的药品
Procedure number: EMEA/H/A-31/1471
程序编号：EMEA/H/A-31/1471
Amlodipine-Valsartan Mylan EMEA/H/A-31/1471/C/4037/0004
Copalia EMEA/H/A-31/1471/C/774/0099
Copalia HCT EMEA/H/A-31/1471/C/1159/0069
Dafiro EMEA/H/A-31/1471/C/776/0101
Dafiro HCT EMEA/H/A-31/1471/C/1160/0070
Entresto EMEA/H/A-31/1471/C/4062/0021
Exforge EMEA/H/A-31/1471/C/716/0098
Exforge HCT EMEA/H/A-31/1471/C/1068/0068
Neparvis EMEA/H/A-31/1471/C/4343/0020
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Procedural step: |
Date |
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Notification: |
5 July 2018 |
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Start of the procedure (CHMP): |
16 July 2018 |
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List of questions: |
16 July 2018 |
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Submission of responses: |
30 July 2018 |
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Re-start of the procedure: |
23 August 2018 |
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Rapporteur/Co-rapporteur assessment report(s) circulated to CHMP: |
10 September 2018 |
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Comments: |
13 September 2018 |
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Updated Rapporteur/co-rapporteur assessment reports circulated to CHMP: |
14 September 2018 |
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CHMP list of outstanding issues /CHMP opinion: |
20 September 2018 |
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程序步骤 |
日期 |
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通知 |
2018-07-05 |
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程序启动(CHMP) |
2018-07-16 |
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问题清单 |
2018-07-16 |
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提交回复 |
2018-07-30 |
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重启程序 |
2018-08-23 |
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主审国/副审国审评报告转至CHMP |
2018-09-10 |
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提出审核意见 |
2018-09-13 |
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主审国/副审国更新后的审评报告转至CHMP |
2018-09-14 |
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CHMP列出重点问题/CHMP观点 |
2018-09-20 |
EMA对缬沙坦中杂质审核的更新
17 July 2018
EMA/485921/2018
Update on review of valsartan medicinesfollowing detection of impurity in active substance
Assessing potential impact on patients ispriority
活性物质中检出杂质后对缬沙坦药品的审核更新
优先评估对患者的潜在影响
EMA’s review of valsartan medicines inrelation to an impurity found in the valsartan active substance manufactured by Zhejiang Huahai Pharmaceuticals is now underway.
EMA因在浙江华海药业所生产的缬沙坦活性物质中发现杂质而启动的对缬沙坦药品的审核目前正在进行中。
The impurity – N-nitrosodimethylamine (NDMA)– is classified as a probable human carcinogen which, based on results from laboratory tests, may cause cancer with long-term use.
该杂质—N-二甲基亚硝胺（NDMA）–基于实验室测试被分类为可能的人体致癌物，它可能会因长期使用而致癌。
Over the past two weeks, national medicines authorities have been recalling medicines containing valsartan from Zhejiang Huahai, and these medicines should no longer be available in pharmacies across the EU.
在过去2周，国家药监局已经召回了含有浙江华海API的药品，这些药品不应在EU的药房出现了。
While further assessment is needed, there isno immediate risk and patients taking valsartan are advised not to stop their treatments unless they have been advised to do so by their pharmacist or doctor. Healthcare professionals should follow specific advice from national authorities concerning medicines in their country.
但还需要进行进一步评估。目前并无直接风险，正在服用缬沙坦的患者并不建议其停止治疗，其药师或医生建议如此者除外。专业医疗人员应遵从国家药监局关于其所在国药品的具体建议。
It is still too early to provide information on the longer term risk NDMA may have posed for patients. EMA has made this aspect of the review a priority and will update the public as soon as new information becomes available.
目前提供NDMA对患者可能产生的更长期风险相关信息为时尚早。EMA已将此审核作为优先事项处置，并将在获得新资料时即刻向公众更新。
EMA will consult toxicology experts to better understand the impact that use of medicines containing the NDMA impurity may have on patients. The review will also seek to establish how long and atwhat levels patients might have been exposed to NDMA.
EMA将咨询毒理学专家，以更好地了解使用含有NDMA杂质的药品对患者可能产生的影响。审核亦将了解患者可能暴露于NDMA的时长及水平。
NDMA is an unexpected impurity that was not detected by routine tests carried out by Zhejiang Huahai. EMA is now gathering details of the company’s manufacturing processes, following changes introduced in 2012 that are believed to have produced NDMA as a side product.
NDMA是一种非预期杂质，浙江华海所执行的常规检查并不能检出。EMA现在正在收集该公司在2012年引入变更之后的生产工艺的详细信息，EMA相信正是该变更生成了副产物NDMA。
EMA is also working closely with national authorities to evaluate whether other medicines containing valsartan (other than those being recalled) could also contain the same impurity.
EMA亦正与国家药监局紧密合作，评估是否有其它含有缬沙坦的药品（除了正被召回的那些以外）可能含有相同杂质。
Further information about the review of valsartan, including the questions being addressed to companies, is available on EMA’s website.
关于缬沙坦审核的进一步消息，包括需要相关公司回答的问题，都发布在EMA官网上。
More about the medicine 关于药品的更多信息
Valsartan is an angiotensin-II-receptorantagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.
缬沙坦是一种血管紧张素受体拮抗剂，用于治疗高血压、近期心脏病发作和心力衰竭。有单方药和复方药。
The review covers all medicines that contain valsartan supplied by Zhejiang Huahai Pharmaceuticals. As a precaution, thereview will also consider whether other valsartan medicines may be affected.
本次审核覆盖所有含有浙江华海药业供应的缬沙坦的药品。作为预防措施，审核亦将考虑是否有其它缬沙坦药品可能受到影响。
More about the procedure 关于程序的更多信息
The review of valsartan medicines in relation to NDMA found in the active substance from Zhejiang Huahai Pharmaceuticals was triggered by the European Commission on 5 July 2018 Article 31 of Directive 2001/83/EC.
对在浙江华海药业的API中发现NDMA有关的缬沙坦药品的审核是由EC于2018年7月5日依指令2001/83/EC第31启动的。
The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
负责人药问题的CHMP正在执行的审核将采纳EMA的意见。CHMP的观点将提交给EC，EC将签发最终强制法令，适用于所有EU成员国。
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