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EMA亚硝胺事件时间线

以下为EMA--沙坦类药品中亚硝胺杂质习得教训(Lessons learnt from presence of N-nitrosamine impurities in sartan medicines
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以下为EMA--沙坦类药品中亚硝胺杂质习得教训(Lessons learnt from presence of N-nitrosamine impurities in sartan medicines)中的时间事件表(Timeline of events),第88-91页)
译文仅供参考,原文参见EMA官网
6 June 2018 Zhejiang Huahai informed by potential customer of impurity in its valsartan API
20180606潜在客户通知浙江华海其缬沙坦API中杂质问题
20 June 2018 Zhejiang Huahai tells customers to put use of its valsartan API on hold after preliminary investigation
20180820浙江华海在初步调查之后告诉客户暂扣其缬沙坦API
25 June 2018 Zhejiang Huahai tells customers of presence of NDMA in its valsartan API
20180625浙江华海告诉客户在其缬沙坦API中检出NDMA
26 June 2018 Information related to the presence of NDMA in valsartan from Zhejiang Huahai is disseminated within the Rapid Alert Network
20180626浙江华海中缬沙坦检出NDMA的消息在快速警示网络中传播
28June 2018 EU network holds the first Incident Review Network (IRN) and the first Rapid Alert Network (RAN) teleconferences
20180628 EU网络召开首次事故审核网络(IRN)和首次快速警示网络(RAN)电话会议
2July 2018 2nd IRN teleconference and 2nd RAN teleconference
20180702第2次IRN和第2次RAN电话会议
3July 2018 3rd RAN teleconference
20180703第3次RAN电话会议
5July 2018 3rd IRN teleconference
20180705第3次IRN电话会议
5July 2018 EC triggers Article 31 review of valsartan medicines; EMA announces start of review and recalls on its website
20180705 EC启动31条款对缬沙坦药品进行审核,EMA在其官网宣布启动审核和召回
6July 2018 4th RAN teleconference
20180706第4次RAN电话会议
9July 2018 EDQM suspends Zhejiang Huahai’s valsartan CEP (CEP 2010-072)
20180709 EDQM搁置浙江华海的缬沙坦CEP(CEP 2010-072)
12 July 2018 5th RAN teleconference
20180712第5次RAN电话会议
19 July 2018 6th RAN teleconference
20180719第5次RAN电话会议
30 July 2018 7th RAN teleconference
20180730第7次RAN电话会议
2 August 2018 EMA publishes preliminary risk assessment for NDMA in medicines containing Zhejiang Huahai’s valsartanAPI
20180802 EMA发布含有浙江华海的缬沙坦API的药品NDMA初步风险评估
3 August 2018 Taiwan Food and Drug Administration alerts regulators of valsartan API from Zhejiang Tianyu and Zhuhai Rundu Pharma (the latter’s API not being present in EU medicines)
20180803台湾食品药品管理局警示受监管公司关于浙江天宇和珠海润都药业缬沙坦问题(后者的API不在EU药品中)
6 August 2018 8th RAN teleconference
20180806第8次RAN电话会议
9 August 2018 4th IRN teleconference
20180809第4次IRN电话会议
9 August 2018 US Food and Drug Administration (FDA) announces the detection of NDMA in valsartan API from Hetero Labs
20180809 USFDA宣布在Hetero Labs的缬沙坦API中检出NDMA
10 August 2018 9th RAN teleconference
20180810第9次RAN电话会议
17 August 2018 EDQM suspends Zhejiang Tianyu’s valsartan CEP (CEP 2013-159)
20180817 EDQM搁置浙江天宇的缬沙坦CEP(CEP 2013-159)
17 August 2018 EDQM suspends Heterolab’s valsartan CEP (CEP 2016-069)
20180817 EDQM搁置Heterolab的缬沙坦CEP(CEP 2016-069)
17 August 2018 10th RAN teleconference
20180817第10次RAN电话会议
29 August 2018 11th RAN teleconference
20180829第11次RAN电话会议
30 August 2018 Zhejiang Huahai confirms the presence of a second N-nitrosamine, NDEA, in some batches of its valsartan API
20180830浙江华海确认在其缬沙坦API的一些批次中检出第二种亚硝胺杂质--NDEA
31 August 2018 12th RAN teleconference
20180831第12次RAN电话会议
5 September 2018 13th RAN teleconference
20180905第13次RAN电话会议
12 September 2018 Study on cancer risk fromNDMA in Denmark published in BMJ
20180912丹麦的NDMA癌症风险研究发布BMJ上
13 September 2018 EMA publishes updated NDMA risk assessment
20180913 EMA发布NDMA风险评估更新
14 September 2018 OMCL in Germany detectstrace amounts of NDEA in losartan from Hetero Labs
20180914德国的OMCL在Hetero Labs的氯沙坦中检出痕量NDEA
17 September 2018 14th RAN teleconference
20180917第14次RAN电话会议
18 September 2018 5th IRN teleconference
20180919第5次IRN电话会议
20 September 2018 EC extends scope ofArticle 31 review to all sartans with a tetrazole ring
20180920 EC将31条款行动范围扩大至对含四唑环的所有沙坦类产品
24 September 2018 EDQM informs RAN of NDEA in irbesartan from Aurobindo
20180924 EDQM通知RAN在Aurobindo的厄贝沙坦中检出NDEA
24 September 2018 15th RAN teleconference
20180924第15次RAN电话会议
28 September 2018 Following EU inspection, AIFA publishes statement of GMP non-compliance for valsartan API from Zhejiang Huahai
20180928在EU检查之后,AIFA发布了浙江华海缬沙坦API的GMP不符合声明
28 September 2018 6th IRN teleconference
20180928第6次IRN电话会议
4 October 2018 16th RAN teleconference
20181004第16次RAN电话会议
8 October 2018 EDQM suspends Aurobindo’sCEP for irbesartan (CEP 2009-283)
20181008 EDQM搁置Aurobindo的厄贝沙坦CEP(2009-283)
11 October 2018 17th RAN teleconference
20181011第17次RAN电话会议
23 October 2018 18th RAN teleconference
20181023第18次RAN电话会议
7 November 2018 Sandoz informs Danish agency of NDEA in losartan from Zhejiang Huahai
20181107 Sandoz通知丹麦当局在浙江华海的氯沙坦中检出NDEA
8 November 2018 Swissmedic issues notification on NDEA in valsartan from Mylan
20181108瑞士发布通知Mylan的缬沙坦中检出NDEA
13 November 2018 19th RAN teleconference
20181113第19次RAN电话会议
14 November 2018 AEMPS inform EMA of NDMAin valsartan from Sun Pharmaceuticals, India
20181114 AEMPS通知EMA在印度SunPharmaceuticals的缬沙坦中检出NDMA
16 November 2018 Some Member States startrecall of medicines containing Mylan valsartan
20181116一些成员国开始召回含有Mylan缬沙坦的药品
16 November 2018 EDQM suspends Mylan CEP for valsartan (CEP 2009-396)
20181116 EDQM搁置Mylan的缬沙坦CEP(CEP 2009-396)
16 November 2018 20th RAN teleconference
20181116第20次RAN电话会议
19 November 2018 BfArM issues notification on NDEA contamination of irbesartan from Divi Laboratories
20181119 BfArM发布通知在Divi Laboratories的厄贝沙坦中检出NDEA
20 November 2018 7th IRN teleconference
20181120第7次IRN电话会议
21 November 2018 21st RAN teleconference
20181121第21次RAN电话会议
5 December 2018 BfArM issues notification of recall for Irbesartan from Divi Laboratories
20181205 BfArM发布通知召回Divi Laboratories的厄贝沙坦
7 December 2018 Health Canada informsEU network of NDIPA in valsartan from Signa de CV
20181207加拿大药监局通知EU网络在Signa de CV的缬沙坦中检出NDIPA
10 December 2018 DIPNA, EIPNA known to bepresent or possibly present in valsartan from Novartis, Mylan and Teva Tapi and candesartan from Aurobindo
20181210已知在诺华、迈兰和Teva Tapi的缬沙坦和Aurobindo坎地沙坦中含有或可能含有DIPNA, EIPNA
NAP 181-14 known to be in valsartan fromNovartis
已知诺华的缬沙坦中有NAP 181-41
13 December 2018 EDQM notifies network of NDEA in valsartan from Aurobindo
20181213 EDQM通知网络在Aurobindo的缬沙坦中检出NDEA
17 December 2018 BfArM sends notification of recall of valsartan from Aurobindo
20181217 BfArM通知召回Aurobindo的缬沙坦
17 December 2018 EDQM suspends Signa deCV’s valsartan CEP 2011-231
20181217 EDQM搁置Signa de CV的缬沙坦CEP(CEP 2011-231)
19 December 2018 EDQM suspends Aurobindo’s CEP 2011-174 for valsartan
20181219 EDQM搁置Aurobindo的缬沙坦CEP(CEP 2011-174)
19 to 21 December 2018 BfArM sends notification of recall of ‘Valsartan Puren’ – API from Aurobindo
20181219-21 BfArM通知召回Aurobindo的缬沙坦普连API
21 December 2018 Poland initiates recallof valsartan from Aurobindo and Valsartan from Signa de CV
20181221波兰启动召回Aurobindo和Signa de CV的缬沙坦
26 December 2018 ANSM informs network ofNDEA above limits in irbesartan and losartan from Zhejiang Huahai
20181226 ANSM通知网络浙江华海的厄贝沙坦和氯沙坦中的NDEA超限
27 December 2018 BfArM informs network of NDEA in losartan from Zhejiang Huahai
20181227 BfArM通知网络浙江华海的氯沙坦中检出NDEA
28 December 2018 MHRA informs network ofNDEA in irbesartan from Zhejiang Huahai
20181228 MHRA通知网络浙江华海的厄贝沙坦中检出NDEA
3 January 2019 MHRA recalls irbesartan from Zhejiang Huahai
20190103 MHRA召回浙江华海的厄贝沙坦
11 January 2019 22nd RAN teleconference
20190111第22次RAN电话会议
14 January 2019 EDQM suspends ZhejiangHuahai’s CEP 2010-033 for irbesartan and CEP 2010-139 losartan potassium
20190114 EDQM搁置浙江华海的厄贝沙坦CEP(CEP 2010-033)和氯沙坦钾的CEP(CEP 2010-139)
22 January 2019 23rd RAN teleconference
20190122第23次RAN电话会议
24 January 2019 EDQM informs network of newimpurity NMBA in losartan from Heterolabs and NDMA in pioglitazone from Heterolabs
20190124 EDQM通知网络在Heterolabs的氯沙坦中检出NMBA新杂质,在其吡咯列酮中检出NDMA
25 January 2019 24th RAN teleconference
20190125第24次RAN电话会议
31 January 2019CHMP concludes Article 31review and issues recommendations
20190131 CHMP的31条款审核得出结论,发布建议
7 February 2019 8th IRN teleconference
20190107第8次IRN电话会议
21 February 2019 25th RAN teleconference
20190221第25次RAN电话会议
26 April 2019 EMA and national authorities agree to request some MAHs for pioglitazone to check their processes to rule out the presence of N- nitrosamine impurities
20190426 EMA和国家药监局同意要求吡咯列酮的MAH检查其工艺,排除亚硝胺杂质存在可能性
2 May 2019 European network launcheslessons learnt exercise
20190502欧洲网络发起习得教训活动
2 April 2019 EC publishes first decisionson the Article 31 review of sartans
20190402 EC发31条款沙坦类审核首份决议
17 April 2019 EC publishes final decisions on the Article 31 review of sartans
20190417 EC发布31条款沙坦类审核最终决议

发布于 2020-07-06 15:48:58 © 著作权归作者所有
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