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NETHERLANDS | CCMO Introduces New Participant Information Letter for WMO Research — IVO to Become Mandatory from January 2027

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NETHERLANDS | CCMO Introduces New Participant Information Letter for WMO Research — IVO to Become Mandatory from January 20272026-08-10T16:30:09+00:00

EU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing

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EU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing2026-08-10T16:25:17+00:00

CHINA | CDE Consults on RWE Communication Guideline for Expanding Paediatric Indications of Marketed Drugs

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CHINA | CDE Consults on RWE Communication Guideline for Expanding Paediatric Indications of Marketed Drugs2026-08-10T16:20:04+00:00

CANADA | Panel on Research Ethics Publishes Broad Consent Guidance — Clarifying Future Use of Data and Human Biological Materials

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CANADA | Panel on Research Ethics Publishes Broad Consent Guidance — Clarifying Future Use of Data and Human Biological Materials2026-08-10T16:20:37+00:00

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
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