The GREG project has been officially launched to address persistent challenges in the generation, implementation, and acceptance of Real-World Evidence (RWE) for medicines, medical devices, and drug-device combinations in Europe.
The GREG Initiative Will Tackle Persistent Challenges in Real-World Evidence
While the interest and ability to use Real-World Data (RWD) sources to generate RWE have grown rapidly worldwide, challenges remain in applying European guidelines consistently and reliably. Numerous initiatives have created multiple guidelines and recommendations for RWD and RWE use, but barriers in practical implementation continue to limit acceptance by patients, healthcare professionals (HCPs), regulators, Health Technology Assessment (HTA) agencies, payers, pharmaceutical and medical technology industries, contract research organizations, and data science companies.
A key challenge lies in the variability of how RWE is adopted by regulators and HTA bodies. Medicinal products, for example, are assessed by the European Medicines Agency and National Competent Authorities, whereas medical devices are evaluated by Notified Bodies. Drug-device combinations may follow either regulatory path depending on their classification. Also, existing guidance from regulators and HTA bodies lacks clarity on expected evidence standards across different use cases, countries, and contexts for both medicines and devices.
These complexities increase the difficulty of preparing RWE submissions, potentially slowing or limiting access to efficacious, cost-effective, and safe health technologies for European patients. The GREG project directly addresses these persistent challenges by working to clarify expectations, harmonise approaches, and develop practical tools and guidance to support more consistent and effective use of RWE across regulatory and HTA decision-making. Through collaboration with key stakeholders, GREG aims to help unlock the full potential of RWE to improve patient access and outcomes across Europe and beyond.
A Consortium Built on Expertise and Collaboration
To tackle these challenges, the GREG consortium has been recently established, uniting leaders from key European RWE initiatives, including academia, regulators, HTA agencies, NGOs, project management experts, and industry representatives across medicines, medical devices, and drug-device sectors. The consortium’s expertise is grounded in extensive involvement with other landmark EU funded projects, alongside scientific expertise in regulatory science, data science, and clinical development.
This unique multidisciplinary partnership is well-positioned to make a significant impact on European RWE practices.
Project Aims
The overarching aim of the GREG project is to develop, pilot-test, and disseminate evidence-based guidance and practical tools to support the reliable use of RWE in regulatory and HTA decision-making for medicines, medical devices, and drug-device combinations.
Planned outputs include:
- Evidence-based guidance documents co-created with end users.
- Online resources and software tools to facilitate adoption and usability.
- Structured templates and practical submission documents designed for consistency and quality.
- Training programmes for regulators, HTA bodies, healthcare professionals, and industry sponsors.
These resources will address barriers faced by stakeholders and promote more consistent and robust RWE submissions. The ultimate goal is to enable faster patient access to innovative, safe, and cost-effective health technologies.
Building on European RWE Initiatives
The GREG project will leverage lessons learned from existing European RWE initiatives to ensure that its outputs are scientifically rigorous, user-centric, and practically applicable. The consortium will actively engage with regulators, HTA bodies, healthcare professionals, industry partners and patients to co-design and validate its tools and guidance.
Pilot testing with key decision-making bodies is planned to support endorsement and alignment, fostering harmonised assessment practices across Europe.
For further information, check our press release, and follow the progress of the GREG project through our website and LinkedIn page.
