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EU | Council Position on Pharma Package Broadens Post-Authorisation Study Powers and RWD Recognition

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EU | Council Position on Pharma Package Broadens Post-Authorisation Study Powers and RWD Recognition2026-10-18T09:17:29+00:00

EU | Revised GVP Module III Strengthens PV Oversight Across NIS, While Imposed-PASS Registration Becomes Legally Binding

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EU | Revised GVP Module III Strengthens PV Oversight Across NIS, While Imposed-PASS Registration Becomes Legally Binding2026-10-18T09:13:23+00:00

EU | JRC Warns Biological AI Is Advancing Faster Than Its Real-World Readiness — Strong Performance Does Not Yet Mean Models Are Ready for Clinical Use

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EU | JRC Warns Biological AI Is Advancing Faster Than Its Real-World Readiness — Strong Performance Does Not Yet Mean Models Are Ready for Clinical Use2026-09-12T16:40:21+00:00

EU | EMA and HMA Consult on Data Standards Framework — Formalising How the Regulatory Network Manages Data Standards

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EU | EMA and HMA Consult on Data Standards Framework — Formalising How the Regulatory Network Manages Data Standards2026-09-12T15:47:45+00:00

EU | EMA Consults on Qualification of Multinational MS Registry Network for Post-Authorisation Safety Studies

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EU | EMA Consults on Qualification of Multinational MS Registry Network for Post-Authorisation Safety Studies2026-09-12T15:32:44+00:00

EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications

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EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications2026-09-12T15:27:59+00:00

EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing

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EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing2026-09-12T15:23:35+00:00
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