Insights into Early Interactions on Innovative Developments with European Regulators.

IF 2 4区医学 Q4 MEDICAL INFORMATICS

Therapeutic innovation & regulatory science Pub Date : 2024-11-01 Epub Date: 2024-08-30 DOI:10.1007/s43441-024-00686-7

David W Uster, Valentina Cordo', Emmanuel Cormier, Falk Ehmann

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Abstract

Introduction: The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology developers to enable innovation during early drug development stages through ITF briefing meetings.

Aim: To reflect on the current pace of innovation and to assess the potential of ITF stakeholder interactions, a comprehensive analysis of the ITF briefing meetings held between 2021 and 2022 was conducted with a focus on individual questions raised by the developers and the related feedback provided by the European regulators.

Methods: Questions raised during ITF briefing meetings were extracted and categorised into main and sub-categories, revealing different themes across the whole medicine development process such as manufacturing technologies, pre-clinical developments, and clinically relevant questions.

Results: There was positive feedback from regulators who gave initial guidance in 85% of the answers, provided concrete examples in 20% of the answers and recommended to continue discussions through additional regulatory procedures in 22% of the answers.

Conclusion: This analysis frames the content and the type of topics discussed during ITF briefing meetings. Moreover, it describes the type of regulatory feedback provided to medicine developers and identified potential for improvement of these early interactions. Therefore, this analysis emphasises the role of ITF briefing meetings in fostering innovation in medicine.

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与欧洲监管机构就创新发展进行早期互动的启示。

简介：目的：为了反思当前的创新步伐并评估 ITF 利益相关者互动的潜力，我们对 2021 年至 2022 年期间举行的 ITF 简报会进行了全面分析，重点关注开发人员提出的个别问题以及欧洲监管机构提供的相关反馈：方法：提取 ITF 简报会上提出的问题，并将其分为大类和小类，揭示了整个药品开发过程中的不同主题，如制造技术、临床前开发和临床相关问题：结果：监管机构给予了积极的反馈，在 85% 的答复中提供了初步指导，在 20% 的答复中提供了具体实例，在 22% 的答复中建议通过额外的监管程序继续讨论：本分析报告概括了 ITF 简报会讨论的内容和主题类型。此外，它还描述了向药品开发商提供的监管反馈类型，并确定了这些早期互动的改进潜力。因此，本分析强调了 ITF 简报会在促进医药创新方面的作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY

CiteScore

3.40

自引率

13.30%

发文量

127

期刊介绍： Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations