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-
NORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation GalleryNORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation
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GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research GalleryGREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research
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USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation GalleryUSA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation
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UK | MHRA Consults on Draft Rare Disease Therapies Regulatory Framework — Proposed Investigational Marketing Authorisation Would Embed RWE Into Lifecycle Access Model GalleryUK | MHRA Consults on Draft Rare Disease Therapies Regulatory Framework — Proposed Investigational Marketing Authorisation Would Embed RWE Into Lifecycle Access Model
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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-
