FRANCE | ANSM Links Compassionate Blinatumomab Use to Structured Patient Follow-Up and Evidence Collection
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EU | EMA and HMA Target Interoperable RWD for Duchenne Muscular Dystrophy
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EU | New EHDS Rules Standardise Dataset Discovery for Secondary-Use Research
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UK | Updated Model Agreements Take Effect for Commercial Non-Interventional Studies
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SWEDEN | New TLV Rules Put Prevalence and Incidence Evidence at the Centre of Reimbursement Submissions
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EU | Council Position on Pharma Package Broadens Post-Authorisation Study Powers and RWD Recognition
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EU | Revised GVP Module III Strengthens PV Oversight Across NIS, While Imposed-PASS Registration Becomes Legally Binding
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BRAZIL | INAEP Clarifies Single Ethics Review and AI Use in Human Research — Practical Implications for Multi-Centre NIS
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VIETNAM | Ministry of Health Updates Drug Registration Framework — Post-Authorisation Evidence Requirements Continue
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