背景:欧洲药品管理局创新工作组(ITF)作为医学和技术开发人员的早期联络点,通过ITF简报会在早期药物开发阶段实现创新。
目标:为了反思当前的创新速度,并评估ITF利益相关者互动的潜力,对2021年至2022年之间举行的ITF简报会议进行了全面分析,重点是开发商提出的个别问题以及欧洲监管机构提供的相关反馈。
方法:在ITF简报会议期间提出的问题被提取并分为主要和次要类别,揭示整个医学发展过程中的不同主题,如制造技术,临床前发展,和临床相关问题。
结果:来自监管机构的积极反馈,他们在85%的答案中给出了初步指导,在20%的答案中提供了具体的例子,并建议在22%的答案中通过额外的监管程序继续讨论。
结论:此分析框架的内容和在ITF简报会上讨论的主题类型。此外,它描述了提供给医学开发人员的监管反馈类型,并确定了改善这些早期相互作用的潜力。因此,这项分析强调了ITF简报会在促进医学创新中的作用.
BACKGROUND: 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.
OBJECTIVE: 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.
CONCLUSIONS: 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.