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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

CANADA | CDA Draft Guidance Expands Economic Evaluations to Include Caregiver and Productivity Impacts

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CANADA | CDA Draft Guidance Expands Economic Evaluations to Include Caregiver and Productivity Impacts2026-04-12T12:44:14+00:00

BRAZIL | Ministry of Health Continues Implementation of Law 14,874/2024 Through Governance Appointments and Platform Oversight Measures

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BRAZIL | Ministry of Health Continues Implementation of Law 14,874/2024 Through Governance Appointments and Platform Oversight Measures2026-04-12T12:39:50+00:00

UK | Proportionate Approval Route Introduced for Studies Involving NHS Staff as Research Participants

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UK | Proportionate Approval Route Introduced for Studies Involving NHS Staff as Research Participants2026-03-10T11:34:30+00:00

UK | HRA Advances Digital Transformation of Non-CTIMP Approvals with User-Centred Design Approach

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UK | HRA Advances Digital Transformation of Non-CTIMP Approvals with User-Centred Design Approach2026-03-10T10:28:29+00:00

EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research

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EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research2026-03-10T10:09:24+00:00

EU | EMA Proposes Revision of Good Pharmacogenomic Practice Guideline to Reflect Scientific Advances

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EU | EMA Proposes Revision of Good Pharmacogenomic Practice Guideline to Reflect Scientific Advances2026-01-09T14:29:56+00:00

EU | Editorial Highlights Growing Importance of Real-World Data in Pharmacovigilance and Regulatory Science

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EU | Editorial Highlights Growing Importance of Real-World Data in Pharmacovigilance and Regulatory Science2026-01-09T14:24:01+00:00

USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies

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USA | FDA Draft Guidance on Sex Differences Reinforces Expectations for Non-Interventional Studies2026-01-09T14:18:59+00:00

USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics

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USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics2026-01-09T14:13:46+00:00
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