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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

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 Data2026-06-12T10:16:59+00:00

CHINA | NEW BIOMEDICAL TECHNOLOGIES REGULATION TAKES EFFECT — CREATING A NATIONAL FRAMEWORK FOR CLINICAL RESEARCH, TRANSLATIONAL APPLICATION AND LONG-TERM SAFETY OVERSIGHT

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CHINA | NEW BIOMEDICAL TECHNOLOGIES REGULATION TAKES EFFECT — CREATING A NATIONAL FRAMEWORK FOR CLINICAL RESEARCH, TRANSLATIONAL APPLICATION AND LONG-TERM SAFETY OVERSIGHT2026-06-12T09:56:47+00:00

BRAZIL | INAEP Issues New Operational Guidance to Implement Law No. 14,874/2024 — Strengthening CEP Governance, Review Timelines and SINEP Standardisation

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BRAZIL | INAEP Issues New Operational Guidance to Implement Law No. 14,874/2024 — Strengthening CEP Governance, Review Timelines and SINEP Standardisation2026-06-12T11:57:31+00:00

EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space

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EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space2026-05-14T14:09:14+00:00

US | FDA Advances Digital Pharmacovigilance Modernisation Through New Electronic ICSR Rule and AEMS Public Dashboard

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US | FDA Advances Digital Pharmacovigilance Modernisation Through New Electronic ICSR Rule and AEMS Public Dashboard2026-05-14T14:03:28+00:00

Singapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations

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Singapore | HSA Updates Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTPs — Expanding Lifecycle Pharmacovigilance and Safety Reporting Expectations2026-05-14T13:59:13+00:00

Canada | Health Canada Expands Lifecycle Oversight of Medical Devices Through New Guidance Framework

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Canada | Health Canada Expands Lifecycle Oversight of Medical Devices Through New Guidance Framework2026-05-14T13:53:45+00:00

Brazil | Major Reform of National Research Ethics Oversight Advances Through New INAEP Governance Framework and Regulatory Actions

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Brazil | Major Reform of National Research Ethics Oversight Advances Through New INAEP Governance Framework and Regulatory Actions2026-05-14T13:48:21+00:00
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