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USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance

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USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance2026-04-12T12:35:30+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 Guidance2026-04-12T12:29:12+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 Studies2026-04-12T12:28:08+00:00

EU | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation

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EU | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation2026-04-12T12:28:43+00:00

UK | NICE Launches National HealthTech Access Programme to Accelerate Adoption of Innovative Diagnostics and Digital Tools

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UK | NICE Launches National HealthTech Access Programme to Accelerate Adoption of Innovative Diagnostics and Digital Tools2026-03-10T15:47:25+00:00

GLOBAL | New ICH M15 Guideline Establishes Global Framework for Model-Informed Drug Development

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GLOBAL | New ICH M15 Guideline Establishes Global Framework for Model-Informed Drug Development2026-03-10T15:37:14+00:00

EU | HTA Coordination Group Publishes 2025 Annual Report on First Year of EU HTA Regulation Implementation

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EU | HTA Coordination Group Publishes 2025 Annual Report on First Year of EU HTA Regulation Implementation2026-03-10T15:30:12+00:00

EU | ENCePP Publishes 2025 Annual Activity Report Highlighting New Working Groups and RWE Priorities

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EU | ENCePP Publishes 2025 Annual Activity Report Highlighting New Working Groups and RWE Priorities2026-03-10T11:43:51+00:00

AUSTRALIA | TGA Publishes Guidance on Regulation and Post-Market Responsibilities for Software-Based Medical Devices

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AUSTRALIA | TGA Publishes Guidance on Regulation and Post-Market Responsibilities for Software-Based Medical Devices2026-03-10T11:39:03+00:00
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