Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy

机译：根据符合条件通知政策在加拿大批准的药品的上市后安全警告

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AimsHealth Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review.

机译：加拿大AimsHealth已开发出一种途径来批准疗效和安全性数据有限的药物，即“符合条件通知（NOC / c）”政策。这些药物需要增加安全性报告，但尚未对其上市后安全性进行任何系统的审查。这项研究将NOC / c药物与具有优先级和标准审查的药物的安全警告进行了比较。

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期刊名称 British Journal of Clinical Pharmacology
作者
Joel Lexchin;
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作者单位

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年(卷),期 2015(79),5
年度 2015
页码 847–859
总页数 13
原文格式 PDF
正文语种
中图分类药学;
关键词
Health Canada new active substances post-market safety warnings priority review standard review;

机译：加拿大卫生部;新活性物质;上市后安全警告;优先审查;标准审查;

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专利

1. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy [J] . Lexchin Joel British Journal of Clinical Pharmacology . 2015,第5期

机译：根据《符合条件通知》政策在加拿大批准的药品的上市后安全警告
2. Post‐market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy [J] . Lexchin Joel British journal of clinical pharmacology . 2015,第5期

机译：根据《符合条件通知》政策在加拿大批准的药品的上市后安全警告
3. Health Canada’s Use of its Notice of Compliance With Conditions Drug Approval Policy: A Retrospective Cohort Analysis [J] . Joel Lexchin International journal of health services: planning, administration, evaluation . 2019,第2期

机译：卫生加拿大使用其遵守条件的遵守通知药物批准政策：回顾性队列分析
4. COMPLIANCE OF PRIVACY POLICIES WITH LEGAL REGULATIONS - Compliance of Privacy Policies with Canadian PIPEDA [C] . Nolan Zhang, Peter Bodorik, Dawn Jutla International Joint Conference on E-Business and Telecommunications . 2007

机译：与法律规定的隐私政策遵守 - 与加拿大Pipeda的隐私政策合规
5. Study on impacts of promotion of generic drug utilization on spontaneous adverse event reports and drug safety assessment at the post-market stage [D] . TAKAMI, Akina 2019

机译：上市后阶段推广仿制药利用对自发不良事件报告和药物安全评估的影响
6. Publication of confirmatory studies required by Health Canada for drugs approved under a Notice of Compliance with conditions: a cohort study [O] . Joel Lexchin 2017

机译：公布加拿大卫生部要求对符合条件通知书批准的药物进行的验证性研究：队列研究
7. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy [O] . Joel Lexchin 2015

机译：在遵守条件政策的通知下，加拿大批准的药物后市场安全警告
8. Guidance for FDA Staff and Industry: Marketed Unapproved Drugs. Compliance Policy Guide. Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (September 19, 2011) [R] . 2011

机译：FDa工作人员和行业指南：未经批准的未经批准的药物。合规政策指南。秒。 440.100未经批准的NDa或aNDa上市的新药（2011年9月19日）

Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy

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