Many IMI and IHI projects are developing results/outputs such as novel tools / methodologies, biomarkers / endpoints, patient reported outcomes, that may impact on health-related decision-making processes, including decision-making processes by regulatory authorities. For this reason, we encourage all applicants and project consortia to start thinking about any potential regulatory impacts of their work as soon as possible in order to build a strategy plan to deliver outputs that may require regulatory endorsement. This will help the project to ensure that the development of the project's results meets the regulatory standards required to be implemented in formal regulatory pathways and ultimately address patients' and public health needs.
In 2024, IHI produced a new guide for applicants and project consortia on regulatory considerations for IMI and IHI projects.
As the name suggests, the document is designed to raise awareness of applicants and project consortia on regulatory aspects to be considered when preparing a proposal and during project implementation. It is particularly relevant for research topics/projects that contribute to regulatory science and whose results are intended to be for regulatory use. The document also provides an overview of existing opportunities for regulatory support services and processes to assist applicants and consortia in their planning for engagement with regulators.
It focuses particularly on services and processes available at the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), including the EMA qualification procedure and FDA qualification program for regulatory acceptance of tools to be used for research and development into pharmaceuticals.
- European Medicines Agency (EMA) page on qualification of novel methodologies for medicine development
- U.S. Food & Drug Administration (FDA) page on Drug Development Tools Qualification Programs
In February 2024, IHI held a Regulatory Science Summit which brought together representatives of regulatory agencies for medicinal products and devices as well as people from the European Commission, and IHI’s industry members. Over the course of two days, the group discussed challenges and opportunities in regulatory science that could be addressed by a cross-sectoral public-private partnership like IHI. They also explored how to maximise the regulatory impact of IHI projects. The meeting focused on five key areas: rare diseases, paediatrics, real-world data / real-world evidence (RWD/RWE), artificial intelligence (AI) and regulatory sandboxes.
The meeting revealed a shared ambition to transform health by identifying clear research questions that will address public health needs collectively and improve patients' lives, and provided insights into how IHI, as a cross-sectoral public-private partnership providing a unique multi-stakeholder platform, could contribute to regulatory science going forward.
Find out more
The discussions and key takeaways from the discussions are summarised in the summit report and in this news story published shortly after the event.