EMA Archives - rwr-regs

EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making
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EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making

2026, EHDS, EMA, EU, June 2026, Members-Only, Moderate Update

EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making

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EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Makingstuart.mccully2026-07-03T10:19:23+00:00

EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle
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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle

2026, AI, EMA, EU, June 2026, Members-Only, Minor Update

EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle

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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecyclestuart.mccully2026-07-03T10:10:25+00:00

EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data
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EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data

2026, EMA, EU, May 2026, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data

EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data

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EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Datastuart.mccully2026-06-12T10:16:59+00:00

EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance
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EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance

2026, EMA, EU, March 2026, Members-Only, Significant Update

EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance

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EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidancestuart.mccully2026-04-12T12:29:12+00:00

EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies
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EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies

2026, EMA, EU, March 2026, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update

EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies

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EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studiesstuart.mccully2026-04-12T12:28:08+00:00

EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research
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EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research

2026, EMA, EU, February 2026, Members-Only, Moderate Update, Pharmacovigilance

EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research

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EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Researchstuart.mccully2026-03-10T10:09:24+00:00

EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Development
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EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Development

2026, AI, EMA, January 2026, Members-Only, Minor Update

EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Development

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EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Developmentstuart.mccully2026-02-16T10:31:53+00:00

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 Practice

2026, EMA, EU, ICH, January 2026, Members-Only, Pharmacovigilance, Significant Update

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 Practicestuart.mccully2026-02-16T10:11:05+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 Gap

2025, December 2025, EMA, EU, Members-Only, Minor Update, RWD to Support Reg Decisions

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 Gapstuart.mccully2026-01-09T14:35:29+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 Advances

2025, December 2025, EMA, EU, Members-Only, Moderate Update

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 Advancesstuart.mccully2026-01-09T14:29:56+00:00

EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making

EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle

EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data

EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance

EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies

EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research

EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Development

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

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

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

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