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EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice

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EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice2026-02-16T10:11:05+00:00

EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 2026

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EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 20262026-02-16T09:57:38+00:00

GLOBAL | ICH Concept Paper Endorsed for RWE Guideline on Medicines Effectiveness (ICH E23)

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GLOBAL | ICH Concept Paper Endorsed for RWE Guideline on Medicines Effectiveness (ICH E23)2026-01-09T14:48:31+00:00

EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health

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EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health2026-01-09T14:39:58+00:00

EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap

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EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap2026-01-09T14:35:29+00:00

EU | EMA Proposes Revision of Good Pharmacogenomic Practice Guideline to Reflect Scientific Advances

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EU | EMA Proposes Revision of Good Pharmacogenomic Practice Guideline to Reflect Scientific Advances2026-01-09T14:29:56+00:00

EU | Editorial Highlights Growing Importance of Real-World Data in Pharmacovigilance and Regulatory Science

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EU | Editorial Highlights Growing Importance of Real-World Data in Pharmacovigilance and Regulatory Science2026-01-09T14:24:01+00:00

USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies

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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies2026-01-09T14:18:59+00:00

USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics

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USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics2026-01-09T14:13:46+00:00
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