GLOBAL | ICH Adopts Revised Guideline on Post-Approval Safety Data – ICH E2D(R1)
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EU | EMA Proposes New Standards for Patient Experience Data Across the Medicine Lifecycle
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GLOBAL | ICH Adopts Final Guideline on Non-Interventional Safety Studies Using Real-World Data (ICH M14)
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BRAZIL | Brazilian Society of Bioethics Files Lawsuit Against Law 14,874/2024
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AUSTRALIA | Implementation of National Statement on Ethics 2025 Delayed until 2026
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UK | New Clinical Trials Regulations Introduce Mandatory Participant Result Sharing — Implications for RWR Transparency
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EU | Launch of GREG: A Landmark Initiative to Strengthen RWE Practices
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UK | Medical Device Post-Market Surveillance Regulation (in force 16 June 2025)
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SWITZERLAND | swissdamed UDI Module Goes Live — Mandatory Device Registration from July 2026
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