Key messages 

• GREG is a five-year, 26.2 million euros initiative that unites 29 partner organisations to advance Real-World Evidence (RWE) practices for the development and evaluation of medicines and medical devices in Europe. 
• GREG will provide evidence-based guidance and tools to help generate and use RWE to inform regulatory and Health Technology Assessment (HTA) decision-making. 
• GREG will carry out Regulatory and HTA use case studies to map relevant topics, needs, and barriers, supporting the development of practical guidance and tools. 

Sophia Antipolis, 13 May 2025: The GREG project — Testing, improving, and co-creating Guidance and Tools for Real World Evidence Generation and Use for Decision-Making in Europe — has been officially launched. 

GREG is a public-private partnership supported by the Innovative Health Initiative Joint Undertaking (IHI JU), set to impact Real-World Evidence practices in Europe. The GREG initiative aims to create, test, and share practical, evidence-based guidance and tools to help generate and use RWE. By improving how RWE informs the development and evaluation of medicines, medical devices, and drug-device combinations, we will support better decision-making for regulators and HTA bodies. 

Starting 1 May, 2025, the five-year project has a budget of €26.2 million, of which €13.2 million is requested to be funded by IHI, and €13.0 million is committed by industry.  

The GREG project unites 29 partners from 15 countries, including the European Society of Cardiology (ESC). The ESC will lead efforts to engage patients, analyse data through federated methods, and promote a patient-centred approach. 

Speaking on behalf of the ESC, Prof. Lars Wallentin, ESC EuroHeart Executive Committee Chair said; “By creating new tools for federated analyses, the GREG project will significantly improve our ability to gather crucial data on the quality of care and develop new treatment strategies for patients with cardiovascular diseases. By working in this project, we aim to make a real difference in the lives of patients and help clinicians provide better care.” 

RWE is evidence derived from the analysis of Real-World Data (RWD), which is data relating to patient health status or the delivery of health care from sources other than clinical trials. Examples of RWD include hospital data and electronic health records. GREG will support better decision-making using RWE, leading to faster market entry of medical products and improved access to healthcare technologies and innovations, meeting both patient needs and the needs of diverse European healthcare systems. 

In order to respond in an agile way to needs for guidance and tools throughout the project, an iterative approach will be followed to develop, test, and disseminate the GREG guidance and tools. We will use the Observational Medical Outcomes Partnership (OMOP) Common Data Model and leverage the European Health Data and Evidence Network (EHDEN) Foundation and other datasets to engage key European data partners for the testing of our proposed methods, tools, and guidance. 

Daniel Prieto Alhambra, Project Coordinator, Erasmus University Medical Center: “As RWE needs increase, there is a clear need for alignment on the best methods, data, and tools for the generation and use of this evidence to inform the development and evaluation of medicines and devices. GREG will deploy a dedicated team of experts to review existing guidelines, fill the gaps in the literature, and generate and pilot-test evidence-based guidance and tools for better RWE generation in Europe.” 

A selection of Regulatory and HTA use cases will be reviewed to map relevant topics, needs, and barriers, facilitating consistent learnings, and the development of the above-mentioned guidance and tools. Followed by a review of existing RWE guidelines and discussions with dedicated regulatory and HTA expert fora, a living library of use cases will be developed, highlighting scenarios where RWE plays a crucial role in the regulatory and HTA process. This effort will involve engagement with key ongoing and upcoming RWE initiatives focused on regulatory action, as well as collaboration with the European Medicines Agency, National Competent Authorities, Notified Bodies, and relevant industry stakeholders. 

Stay informed about the latest advancements from the GREG initiative as we commence on an exciting journey to revolutionize Real-World Evidence practices across Europe. 

ENDS