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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

BRAZIL | Ministry of Health Advances Implementation of Law 14,874/2024 Through Platform Reform and Governance Measures

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BRAZIL | Ministry of Health Advances Implementation of Law 14,874/2024 Through Platform Reform and Governance Measures2026-03-10T10:04:17+00:00

VIETNAM | New Data Protection Law and Decree Set Out Stringent Rules with Real-World Research Implications

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VIETNAM | New Data Protection Law and Decree Set Out Stringent Rules with Real-World Research Implications2026-02-16T10:20:58+00:00

UK | HRA Overhauls Non-CTIMP Terminology, Modification Processes and Transparency Requirements — Implementation from 28 April 2026

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UK | HRA Overhauls Non-CTIMP Terminology, Modification Processes and Transparency Requirements — Implementation from 28 April 20262026-02-16T10:16:14+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 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

ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines

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ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines2026-01-09T12:36:06+00:00
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