The work within Real4Reg is in line with existing European programs. All these initiatives and projects address regulatory and HTA needs within the context of Real-World Evidence (RWE) and are promoting the exchange of knowledge on data sources and facilitating cross-border AI-based research activities.
MetReal Cluster
Our project takes part in the MetReal cluster, gathering six projects funded by the European Union under the same topic “New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment”. The main goal of the initiatives is to generate and share knowledge on methods for the analyses of RWD, in order to facilitate and improve regulatory-decision making and HTA. The consortiums are composed of very different institutions, for example regulatory and HTA agencies, universities, patients’ organisations, hospitals, and private health companies.
The MetReal cluster collaborative work is promoting synergies between projects, by sharing experiences and joint activities. The latest Multistakeholder MetReal Cluster Workshop took place at the Danish Medicines Agency (Copenhagen, Denmark), on 2-3 March 2026. Besides meetings, the MetReal cluster also collaborates in scientific publications, for example in the elaboration of the first joint paper “Towards the use of real-world data for regulatory and health technology assessment decision-making: experiences and recommendations from six EU-funded projects”, which is in the late stages of preparation.
The other five MetReal projects are:
INSAFEDARE website
More-EUROPA website
ONCOVALUE website
REALM website
REDDIE website
European Health Data Space (EHDS)
EHDS is an initiative by the European Union to create a secure and decentralised digital platform for the exchange and sharing of health data across member states. It aims to improve health research, patient care, and disease prevention by facilitating access to high-quality health data while ensuring patient privacy and data protection.
Data Analysis and Real-World Interrogation Network (DARWIN EU®)
The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real-world healthcare databases across the European Union (EU). This capability is called the Data Analysis and Real-World Interrogation Network (DARWIN EU®).
Towards European Health Data Space (TEHDAS)
Towards European Health Data Space (TEHDAS) is a European Union initiative aimed at creating a secure and privacy-preserving environment for the sharing and processing of health data across Europe. The goal is to enhance research and innovation, improve healthcare delivery and outcomes, and strengthen the resilience of health systems.