监管机构接受生物标记物的要求

Q3 Medicine
Hilke Zander, Jörg Engelbergs
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引用次数: 0

摘要

一般来说,生物标志物可以提高医药产品开发的成功率,从而加快新疗法的推出,改善获益与风险之间的关系。因此,基于预测性生物标记物的患者识别在所有治疗领域都变得越来越重要[1]。随着预测性生物标记物引导的个性化(精准)医疗的应用日益广泛,需要发现新型生物标记物作为生理病理状况的可测量指标[2]。生物标志物可用于诊断和预后、监测疾病进展,也可用于选择最有效的疗法和预测治疗结果[3, 4]。本文简要介绍了生物标记物的监管定义以及欧洲药品管理局(EMA)的生物标记物鉴定程序。随着形势的不断发展,关于体外医疗器械(IVDR)的新法规(欧盟)2017/746[5]对欧盟 IVD 法律框架引入了重要变化,特别是首次从法律上定义了 "辅助诊断 "设备(CDx)。本文强调了 CDx 和医药产品的代码开发所面临的挑战,为这一复杂的监管领域提供了科学监管方面的考虑因素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Requirements for regulatory acceptance of biomarkers

Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit–risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVDR) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific–regulatory considerations in this complex regulatory field.

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来源期刊
Allergo Journal International
Allergo Journal International Medicine-Immunology and Allergy
CiteScore
4.60
自引率
0.00%
发文量
31
期刊介绍: Allergo Journal International is the official Journal of the German Society for Applied Allergology (AeDA) and the Austrian Society for Allergology and Immunology (ÖGAI). The journal is a forum for the communication and exchange of ideas concerning the various aspects of allergy (including related fields such as clinical immunology and environmental medicine) and promotes German allergy research in an international context. The aim of Allergo Journal International is to provide state of the art information for all medical and scientific disciplines that deal with allergic, immunological and environmental diseases. Allergo Journal International publishes original articles, reviews, short communications, case reports, and letters to the editor. The articles cover topics such as allergic, immunological and environmental diseases, the latest developments in diagnosis and therapy as well as current research work concerning antigens and allergens and aspects related to occupational and environmental medicine. In addition, it publishes clinical guidelines and position papers approved by expert panels of the German, Austrian and Swiss Allergy Societies. All submissions are reviewed in single-blind fashion by at least two reviewers. Originally, the journal started as a German journal called Allergo Journal back in 1992. Throughout the years, English articles amounted to a considerable portion in Allergo Journal. This was one of the reasons to extract the scientific content and publish it in a separate journal. Hence, Allergo Journal International was born and now is the international continuation of the original German journal. Nowadays, all original content is published in Allergo Journal International first. Later, selected manuscripts will be translated and published in German and included in Allergo Journal.
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