Executive Summary

The IDERHA project has developed draft policy recommendations to support the acceptance and use of Real-World Data (RWD) and Real-World Evidence (RWE) in regulatory and Health Technology Assessment (HTA) decision-making for medicines and medical technologies. These recommendations aim to foster trust, transparency, and global alignment by promoting good research practices, data integrity, and governance. They are aimed at public decision-makers (regulatory authorities and HTA organisations) and researchers (industry, academia, clinical organisations) conducting studies for decision-making.