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EU | EMA Consults on Qualification of Multinational MS Registry Network for Post-Authorisation Safety Studies

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EU | EMA Consults on Qualification of Multinational MS Registry Network for Post-Authorisation Safety Studies2026-09-12T15:32:44+00:00

EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications

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EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications2026-09-12T15:27:59+00:00

EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing

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EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing2026-09-12T15:23:35+00:00

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 | 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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