Requirements for regulatory acceptance of biomarkers

IF 1 Q4 ALLERGY Allergo Journal Pub Date : 2024-12-12 DOI:10.1007/s15007-024-6397-8

Hilke Zander, Jörg Engelbergs

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引用次数: 0

Abstract

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 (IVD) [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.

Cite this as Zander H, Engelbergs J. Requirements for regulatory acceptance of biomarkers. Allergo J Int 2024;33:309-12

https://doi.org/10.1007/s40629-024-00312-w

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生物标记物监管接受要求

一般来说，生物标志物可以提高药品开发的成功率，从而加速新疗法的可用性，改善获益-风险关系。因此，基于预测性生物标志物的患者识别在所有治疗领域变得越来越重要。预测性生物标志物引导的个性化（精确）医学的日益普及，保证了作为生理病理状况可测量指标的新型生物标志物的发现。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治疗方法和预测治疗结果[3,4]。本文简要介绍了生物标志物的监管定义和欧洲药品管理局（EMA）的生物标志物鉴定过程。随着环境的不断发展，体外医疗器械（IVD）[5]的新法规（EU） 2017/746引入了欧盟IVD法律框架的重要变化，特别是首次在法律上定义了“伴随诊断”设备（CDx）。强调CDx和医药产品共同开发的挑战，以便在这个复杂的监管领域提供科学监管考虑。引自Zander H， Engelbergs J.对生物标记物监管接受的要求。[J] .科学进展[J]; 2009;33 (3): 369 - 369

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来源期刊

Allergo Journal ALLERGY-

自引率

18.20%

发文量

175

期刊介绍： The Allergo Journal publishes original articles, reviews and case reports, guidelines and position papers in German and English. The topics concern allergological and immunological clinical pictures, current developments in diagnosis and therapy, research work concerning antigens and allergens and aspects related to occupational and environmental medicine. The quality of the contributions is guaranteed by an international board of editors; all contributions will be reviewed by at least two independent peers.

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