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PERSPECTIVE article

Front. Med.

Sec. Regulatory Science

Volume 12 - 2025 | doi: 10.3389/fmed.2025.1553448

This article is part of the Research Topic Paediatric Drug Development View all 3 articles

Strengthening the European paediatric research -the contribution of the Innovative Health Initiative

Provisionally accepted
  • Innovative Health Initiative, Brussels, Belgium

The final, formatted version of the article will be published soon.

    Children deserve health solutions, including medicines, medical devices and diagnostics, that are adapted to their needs. They should not be left behind when it comes to benefitting from innovations. The introduction of paediatric legislation in the EU and US in the 2000s dramatically changed the regulatory environment by fostering the development of medicines for children. However, the development of paediatric medicines remains challenging, and many needs remain unmet. When it comes to medical devices and in vitro diagnostics (IVDs), very few are designed and intended specifically for use in children, leading doctors to use adult devices and adapt them to fit children. To address the scientific, technical, and operational challenges related to paediatric development, multi-stakeholder collaboration is key. The European public-private partnerships the Innovative Health Initiative (IHI), and its predecessor the Innovative Medicines Initiative (IMI), contribute to advancing paediatric research by bringing together the private health industry sectors and public partners including academia, healthcare providers, patients and carers, regulators, and health technology assessment bodies. Several of their large collaborative research projects have already produced significant results to optimise the development of paediatric medicines. This article looks at these achievements and discusses opportunities for further public-private collaborative research to boost the development of innovative health solutions that address specifically all children’s needs.

    Keywords: Research and innovation, medicines development, collaboration, Public Private Partnerhips, Medical product development

    Received: 07 Jan 2025; Accepted: 24 Feb 2025.

    Copyright: © 2025 Seigneuret. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Nathalie Seigneuret, Innovative Health Initiative, Brussels, Belgium

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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