EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data GalleryEU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data
2026, EMA, EU, May 2026, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data-
Saudi Arabia | SFDA Publishes Framework on the Use of Real-World Data and Real-World Evidence for Regulatory Decision-Making GallerySaudi Arabia | SFDA Publishes Framework on the Use of Real-World Data and Real-World Evidence for Regulatory Decision-Making
2026, April 2026, Members-Only, RWD to Support Reg Decisions, Saudi Arabia, Secondary Use of Existing Data, Significant Update-
USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making GalleryUSA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making
2026, March 2026, Medical Devices, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data-
USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance GalleryUSA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance
2026, March 2026, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update, USA-
- EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies Gallery
EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies
2026, EMA, EU, March 2026, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update -
- USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information Gallery
USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information
2026, January 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA -
- USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence Gallery
USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence
2026, January 2026, Members-Only, Minor Update, Rare Diseases, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA -
- UK | Health Data Research Service Seen as Catalyst for Real-World Research — Alignment with European Health Data Space Highlighted Gallery
UK | Health Data Research Service Seen as Catalyst for Real-World Research — Alignment with European Health Data Space Highlighted
2026, EHDS, January 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK -
- USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics Gallery
USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics
2025, December 2025, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA -
