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BRAZIL | INAEP Clarifies Single Ethical Opinion Model for Multi-centre Research — Strengthening Cooperation Between Research Ethics Committees

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BRAZIL | INAEP Clarifies Single Ethical Opinion Model for Multi-centre Research — Strengthening Cooperation Between Research Ethics Committees2026-07-03T09:38:59+00:00

AUSTRALIA | NHMRC Confirms 2025 National Statement on Ethical Conduct in Human Research — Revised Section 4 to Take Effect from 23 June 2026

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AUSTRALIA | NHMRC Confirms 2025 National Statement on Ethical Conduct in Human Research — Revised Section 4 to Take Effect from 23 June 20262026-07-03T09:34:15+00:00

UAE | Abu Dhabi DOH Issues New Standard for Biomedical Research — Consolidating Oversight of Clinical Trials, RWD, AI and Research Ethics

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UAE | Abu Dhabi DOH Issues New Standard for Biomedical Research — Consolidating Oversight of Clinical Trials, RWD, AI and Research Ethics2026-07-03T09:21:28+00:00

UK | HRA Publishes Two-Year Plan to Support Safe AI-Powered Innovation in Health and Social Care Research

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UK | HRA Publishes Two-Year Plan to Support Safe AI-Powered Innovation in Health and Social Care Research2026-06-12T11:37:14+00:00

UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers

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UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers2026-06-12T11:30:22+00:00

EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate

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EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate2026-06-12T11:07:33+00:00

USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation

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USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation2026-06-12T10:54:30+00:00

UK | MHRA Consults on Draft Rare Disease Therapies Regulatory Framework — Proposed Investigational Marketing Authorisation Would Embed RWE Into Lifecycle Access Model

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UK | MHRA Consults on Draft Rare Disease Therapies Regulatory Framework — Proposed Investigational Marketing Authorisation Would Embed RWE Into Lifecycle Access Model2026-06-12T10:46:19+00:00

UK | MHRA Draft 2026 Medical Device Regulations — International Reliance, UDI and Lifecycle Traceability Move Into Draft Legislative Form

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UK | MHRA Draft 2026 Medical Device Regulations — International Reliance, UDI and Lifecycle Traceability Move Into Draft Legislative Form2026-06-12T10:22:11+00:00
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