EU | EMA Steps Up Women’s Health Initiative — Evidence Gaps, Pregnancy Data and RWE Move Higher on the Regulatory Agenda
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EU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical GalleryEU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical
EU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical
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BRAZIL | INAEP Opens CEP Accreditation Process — High-Risk Research Review Moves Further Into Operational Implementation
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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 GalleryUK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme
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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NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality GalleryNORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality
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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GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data GalleryGLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data
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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EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines
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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle
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USA | FDA Seeks Input on Drug Repurposing to Address Unmet Medical Needs
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