Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union
Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union
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DOI：
10.1158/1078-0432.ccr-13-1571
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发表时间：
2014-03-15
影响因子：
11.5
通讯作者：
Rasi, Guido
中科院分区：
文献类型：
--
作者：
Pignatti, Francesco;Ehmann, Falk;Rasi, Guido
欧盟（EU）医疗器械监管的法律的框架目前正在修订中。欧盟委员会提出了一个新的框架，以确保医疗器械满足需求并确保欧洲公民的安全，旨在建立一个符合目的，更透明，更好地适应科学和技术进步的框架。拟议的新框架被描述为现行制度的演变，保持相同的法律的方法。一项重要的拟议变更是，伴随诊断将不再被视为低风险，并由制造商进行自我认证。根据新的提案，伴随诊断将被分类为高个人风险或中等公共健康风险（C类），并要求由公告机构进行符合性评估。还提出，伴随诊断应要求提供器械用于预期用途的临床实用性证据。在这篇文章中，我们回顾了与伴随诊断相关的欧盟法律的框架，描述了拟议的变化，并总结了欧洲药品管理局提供的科学指导及其在癌症药物开发（包括伴随诊断）方面的监管经验。请参阅CCR焦点部分的所有文章，“精准医学难题：伴随诊断共同开发的方法。"（C）2014年AACR。
The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." (C)2014 AACR.