{"title":"上市许可持有人的非严重药物不良反应缺失的声音","authors":"Jindřich Srba","doi":"10.4172/2167-1052.1000154","DOIUrl":null,"url":null,"abstract":"New pharmacovigilance legislation (Regulation (EU) No. 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament in December 2010. The European Medicines Agency (EMA) is responsible for implementing much of the new legislation, which has been effective since July 2012. One of the impacts concerned to marketing authorisation holders (MAH) is to submit adverse drug reaction (ADR) reports only into EudraVigilance, a safety database superintended by EMA.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"41 4 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2014-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"The Missing Voice of Non-Serious Adverse Drug Reactions from Marketing Authorisation Holders\",\"authors\":\"Jindřich Srba\",\"doi\":\"10.4172/2167-1052.1000154\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"New pharmacovigilance legislation (Regulation (EU) No. 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament in December 2010. The European Medicines Agency (EMA) is responsible for implementing much of the new legislation, which has been effective since July 2012. One of the impacts concerned to marketing authorisation holders (MAH) is to submit adverse drug reaction (ADR) reports only into EudraVigilance, a safety database superintended by EMA.\",\"PeriodicalId\":7385,\"journal\":{\"name\":\"Advances in Pharmacoepidemiology and Drug Safety\",\"volume\":\"41 4 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2014-05-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4172/2167-1052.1000154\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Pharmacoepidemiology and Drug Safety","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4172/2167-1052.1000154","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 2
摘要
欧洲议会于2010年12月通过了新的药物警戒立法(法规(EU) No 1235/2010和指令2010/84/EU)。欧洲药品管理局(EMA)负责实施大部分新法规，该法规自2012年7月起生效。上市许可持有人(MAH)关注的影响之一是仅向EMA监管的安全数据库EudraVigilance提交药物不良反应(ADR)报告。
The Missing Voice of Non-Serious Adverse Drug Reactions from Marketing Authorisation Holders
New pharmacovigilance legislation (Regulation (EU) No. 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament in December 2010. The European Medicines Agency (EMA) is responsible for implementing much of the new legislation, which has been effective since July 2012. One of the impacts concerned to marketing authorisation holders (MAH) is to submit adverse drug reaction (ADR) reports only into EudraVigilance, a safety database superintended by EMA.
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