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Advancing regulatory science with your IHI/IMI project

Read our guide to find out how to maximise the regulatory impact of an IHI/IMI project.

26 March 2024
Our guidance document will help you to maximise the regulatory impact of your IHI or IMI project. Image credit: MMD Creative via Shutterstock.
Our guidance document will help you to maximise the regulatory impact of your IHI or IMI project. Image credit: MMD Creative via Shutterstock.

Health is a highly regulated sector, for good reason – pharmaceutical products and medical technologies must be properly assessed to ensure that they comply with the rules and carry minimal risks for the patient relative to the benefits they provide.

At the Innovative Health Initiative, we work on cutting-edge innovations, and engaging with regulators is recommended for two main reasons: 1) if relevant, ensuring that research project results and outputs can make a smooth transition towards eventual regulatory acceptance; and 2) confirming that project outputs can address regulatory challenges and contribute to regulatory science.

Some of our call topics specifically challenge applicants to develop outputs or results that may be used to inform regulatory decision-making. For instance, the AMYPAD project  investigated how best to integrate the Centiloid method for quantitatively comparing amyloid-PET scans – imaging techniques that are a non-invasive way of diagnosing people with Alzheimer’s – into the clinical routine. The consortium generated evidence that the method could be used to measure the amount of amyloid in the brains of subjects with Alzheimer’s disease in clinical trials. These findings were consolidated into a Biomarker Qualification Opinion document, submitted to the EMA in September 2022. The team received a positive assessment from the EMA and the document is now available for public review on the EMA website.

As another example, the new IHI project HEU-EFS is developing a harmonised approach for early feasibility studies (EFS) for medical devices. These studies constitute a crucial phase in the journey towards device approval, enabling early insights on potentially breakthrough innovations that address patient needs – but the EU does not have any approved procedures in place on how to carry out these types of studies. If the EU has a common, approved framework for carrying out these tests, this will increase the usage of EFS in the EU, boost efficiency in the regulatory process and ensure that patients get access to innovative technologies.

For other projects, engaging with regulators may not be a core component of the project however it’s always important to be aware of the regulatory landscape that your new innovation will exist in. Projects should always ensure that outcomes are on the right track to gain regulatory acceptance or contribute to regulatory science.

We’ve prepared a guidance document to raise awareness amongst applicants and project consortia about the regulatory aspects that should be considered when preparing a proposal as well as over the lifetime of the project. It also outlines how you can engage with regulatory authorities to maximise the results of your IHI research project, using existing opportunities for regulatory support services and processes with a focus on the European Medicines Agency and the US Food and Drug Administration in particular.