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UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme

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UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme2026-07-03T10:54:43+00:00

NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality

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NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality2026-07-03T10:48:13+00:00

GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data

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GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data2026-07-03T10:42:54+00:00

EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making

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EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making2026-07-03T10:19:23+00:00

EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines

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EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines2026-07-03T10:08:49+00:00

EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle

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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle2026-07-03T10:10:25+00:00

UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices

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UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices2026-07-03T09:59:20+00:00

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

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NORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation2026-07-03T09:54:21+00:00

GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research

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GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research2026-07-03T09:48:21+00:00

FRANCE | CNIL Updates MR-003 for Health Research Without Consent — New Requirements for RIPH-3 and Prospective Non-Interventional Studies

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FRANCE | CNIL Updates MR-003 for Health Research Without Consent — New Requirements for RIPH-3 and Prospective Non-Interventional Studies2026-07-03T09:43:36+00:00
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