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BRAZIL | INAEP Finalises Its Decision-Making Body — Ethics-System Reform Moves From Transition to Implementation

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BRAZIL | INAEP Finalises Its Decision-Making Body — Ethics-System Reform Moves From Transition to Implementation2026-09-12T14:57:32+00:00

USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

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USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence2026-09-12T14:52:08+00:00

CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required

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CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required2026-09-12T11:47:27+00:00

UAE | DHA Consolidates Clinical Research Requirements in New Standards — More Defined Framework for Non-Interventional Research Effective January 2027

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UAE | DHA Consolidates Clinical Research Requirements in New Standards — More Defined Framework for Non-Interventional Research Effective January 20272026-09-12T11:42:54+00:00

USA | Reagan-Udall Foundation Meeting Summary Highlights Real-World Data Challenges for At-Home Diagnostics

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USA | Reagan-Udall Foundation Meeting Summary Highlights Real-World Data Challenges for At-Home Diagnostics2026-08-10T17:32:46+00:00

UK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD

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UK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD2026-08-10T17:25:30+00:00

GREECE | Ministerial Decisions Update Clinical Research Site Rules and Digital Safety Communications — Limited but Relevant Signals for RWR

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GREECE | Ministerial Decisions Update Clinical Research Site Rules and Digital Safety Communications — Limited but Relevant Signals for RWR2026-08-10T17:19:14+00:00

GERMANY | Federal Cabinet Approves GeDIG — Draft Law Sets Out National EHDS Secondary-Use Framework

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GERMANY | Federal Cabinet Approves GeDIG — Draft Law Sets Out National EHDS Secondary-Use Framework2026-08-10T17:15:26+00:00

EU | Pharmaceutical Reform Enters Legal-Linguistic Finalisation — EMA Establishes Implementation Governance and Begins Stakeholder Engagement

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EU | Pharmaceutical Reform Enters Legal-Linguistic Finalisation — EMA Establishes Implementation Governance and Begins Stakeholder Engagement2026-08-10T17:10:48+00:00
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