UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices GalleryUK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices
2026, June 2026, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK-
- EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data Gallery
EU | 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 Gallery
Saudi 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 Gallery
USA | 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 Gallery
USA | 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- USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information Gallery
USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information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 -
