MHRA opens a call for evidence on AI for medicines safety, reaching beyond ADMET into validation and governance. https://www.mattheneus.com/editorial/mhra-beyond-admet-ai-medicines-safety-call-for-evidence-2026-09-22 #HTA #RegulatoryAffairs #RWE

Capacity-based exclusions in trial protocols quietly narrow the population HTA bodies must later generalise to. https://www.mattheneus.com/editorial/clinical-trial-protocol-capacity-exclusions-population-relevance-2026-09-25 #HTA #EvidenceSynthesis #RegulatoryAffairs

The European Commission has opened its fourth 2026 request period for joint scientific consultations, with an October deadline. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/european-commission-fourth-joint-scientific-consultation-request-period-october-2026-deadline

The MHRA is proposing a faster scientific advice route and fee rebates from April 2027, reshaping early regulatory engagement budgets. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/mhra-statutory-fees-2027-scientific-advice-accelerated-route-rebate-proposals

Design FMEA didn't push worst-case. That's the root cause.

#DesignControl #RiskManagement #RegulatoryAffairs

Australia opens consumer and clinician seats on its HTA reform reference group. https://www.mattheneus.com/editorial/australia-hta-reform-implementation-reference-group-consumer-clinician-expression-of-interest-2026-09-22 #HTA #RegulatoryAffairs

The European Medicines Agency has opened consultation on clinical requirements for sickle cell disease medicines. https://www.mattheneus.com/editorial/ema-sickle-cell-disease-clinical-requirements-draft-guideline-consultation-2026-09-24 #HTA #RegulatoryAffairs

A patient-specific implant going through 510(k)? My quality brain just sat bolt upright. Want to see that substantial equivalence argument...

#FDACompliance #DesignControl #RegulatoryAffairs

EU coordination group discontinues a joint clinical assessment over unmet dossier information requirements. https://www.mattheneus.com/editorial/european-commission-joint-assessment-discontinued-information-conformity-2026-09-16 #HTA #EvidenceSynthesis #RegulatoryAffairs

FDA approves a vial presentation of Garzulys insulin aspart, expanding delivery options for the fast-acting analogue. https://www.mattheneus.com/editorial/fda-garzulys-insulin-aspart-vial-presentation-approval-2026-09-15 #HTA #RegulatoryAffairs #Pharma

Germany G-BA opens a statement procedure on rewritten quality rules for CAR-T cells and other advanced therapies. https://www.mattheneus.com/editorial/g-ba-atmp-quality-directive-car-t-annex-statement-procedure-2026-09-22 #HTA #RegulatoryAffairs #Pharma

MHRA authorises lurbinectedin maintenance for extensive-stage small cell lung cancer via international recognition route B. https://www.mattheneus.com/editorial/mhra-lurbinectedin-zepzelca-es-sclc-maintenance-authorisation-irp-route-b-2026-09-23 #HTA #RegulatoryAffairs

Europe narrows ipidacrine indications after reviewing legacy evidence, underscoring why old evidence bases still demand modern scrutiny. #HTA #EvidenceSynthesis #RegulatoryAffairs https://www.mattheneus.com/editorial/ema-ipidacrine-indication-restrictions-legacy-evidence-review-2026-09-17

Poland conditionally backed subcutaneous Vyvgart after reviewing direct and indirect comparative evidence. #HTA #EvidenceSynthesis #RegulatoryAffairs https://www.mattheneus.com/editorial/aotmit-vyvgart-subcutaneous-gmg-conditional-reimbursement-adapt-sc-bucher-2026-09-18

Six trials still leave T-tube use in liver-transplant biliary reconstruction without a clear practice conclusion. #HTA #EvidenceSynthesis #RegulatoryAffairs https://www.mattheneus.com/editorial/cochrane-t-tube-liver-transplant-biliary-reconstruction-six-trials-2026-09-22

Poland’s AOTMiT backs Vyjuvek reimbursement, but only with price cuts and an outcomes guarantee. #HTA #Pharma #RegulatoryAffairs https://www.mattheneus.com/editorial/aotmit-vyjuvek-conditional-reimbursement-price-outcomes-guarantee-gem3-2026-09-18

Polish HTA agency backs Vyjuvek only with price cuts and an outcomes guarantee, showing how access can hinge on evidence-linked risk sharing. https://www.mattheneus.com/editorial/aotmit-vyjuvek-conditional-reimbursement-price-outcomes-guarantee-gem3-2026-09-18 #HTA #Pharma #RegulatoryAffairs

Australia backed odevixibat after a price and risk-sharing reset reshaped the reimbursement case. https://www.mattheneus.com/editorial/pbac-odevixibat-bylvay-alagille-early-resubmission-recommendation-2026-08-21 #HTA #RegulatoryAffairs #Pharma

France traced end-of-life safety failures across 385 care incidents. See the patterns regulators and evidence teams should notice. https://www.mattheneus.com/editorial/has-end-of-life-serious-care-incidents-descriptive-safety-analysis-2026-09-16 #HTA #RWE #RegulatoryAffairs

Clinical-trial software providers face a dedicated UK inspection dossier. See what the new MHRA expectations mean. https://www.mattheneus.com/editorial/mhra-computerised-clinical-trial-systems-inspection-dossier-2026-09-22 #HTA #RegulatoryAffairs #Pharma