UK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD GalleryUK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD
2026, EHDS, July 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK
UK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD
Please login to view this page.
GREECE | Ministerial Decisions Update Clinical Research Site Rules and Digital Safety Communications — Limited but Relevant Signals for RWR
Please login to view this page.
GERMANY | Federal Cabinet Approves GeDIG — Draft Law Sets Out National EHDS Secondary-Use Framework
Please login to view this page.
EU | Pharmaceutical Reform Enters Legal-Linguistic Finalisation — EMA Establishes Implementation Governance and Begins Stakeholder Engagement
Please login to view this page.
EU | HTACG Sets AI Transparency Expectations for JCA Dossiers — Human Oversight, Tool Disclosure and Prompt Records Required
Please login to view this page.
EU | EMA Steps Up Women’s Health Initiative — Evidence Gaps, Pregnancy Data and RWE Move Higher on the Regulatory Agenda
Please login to view this page.
EU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical GalleryEU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical
EU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical
Please login to view this page.
BRAZIL | INAEP Opens CEP Accreditation Process — High-Risk Research Review Moves Further Into Operational Implementation
Please login to view this page.
UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme GalleryUK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme
UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme
Please login to view this page.







