EU | Proposed Amendments to Regulation EU/520/2012 Affecting Post-Authorisation Safety Studies
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- UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trials Gallery
UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trials
2025, May 2025, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK
UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trials
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GLOBAL | New CIOMS report: Benefit-Risk Balance for Medicinal Products
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GERMANY | Proposed Centralisation of Data Protection Supervision
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EU | HealthData@EU Central Platform: Release 4
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LUXEMBOURG | New Medicines Agency – Luxembourg Agency for Medicines and Health Products
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UK | Model Non-Interventional Study Agreements (mNISAs) Updated
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MEXICO | New Data Protection Law Reshapes Clinical Research Landscape
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NORWAY | Digitalising the Patient’s Medication List
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