UK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD GalleryUK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD
2026, EHDS, July 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK-
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 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 GalleryEU | 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 GalleryUSA | 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 GalleryUSA | 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-
