- USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance Gallery
USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance
2026, March 2026, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update, USA
USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance
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EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance
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- EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies Gallery
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 | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation
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UK | Regulators Issue Joint Statement on Enabling Innovation in Space Health and Medicine
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UK | NICE Launches National HealthTech Access Programme to Accelerate Adoption of Innovative Diagnostics and Digital Tools
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GLOBAL | New ICH M15 Guideline Establishes Global Framework for Model-Informed Drug Development
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EU | HTA Coordination Group Publishes 2025 Annual Report on First Year of EU HTA Regulation Implementation
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EU | ENCePP Publishes 2025 Annual Activity Report Highlighting New Working Groups and RWE Priorities
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