Engaging with regulators

Guidance on opportunities for projects to interact with regulators.

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.

New! A guide for IMI and IHI projects and applicants on regulatory considerations

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.

Links to relevant pages on the EMA and FDA websites