Germany finalizes the legacy combination-discount register following statutory repeal. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/g-ba-annex-xiia-combination-discount-final-validity-register-2026-10-01

Pick a cert body on price and you'll regret it by audit two. Sector-specific auditors write findings you can fix, not vague majors you spend months defending. #ISO13485 #MedTech #RegulatoryAffairs #AuditReady #MedicalDeviceQMS #qmsWrapper

Project Orbis cases reveal where faster Canadian regulatory review still leaves a critical HTA and access handoff. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/project-orbis-canada-regulatory-hta-access-handoff-2026-10-02

Germany found a small added benefit for Zynyz in first-line anal cancer. Here is what the final G-BA resolution means. https://www.mattheneus.com/editorial/g-ba-retifanlimab-anal-cancer-small-added-benefit-podium303-final-resolution-2026-10-01 #HTA #RegulatoryAffairs #Pharma

A regulatory sandbox application starts with a testable evidence plan and clear learning goals. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/european-regulatory-sandbox-evidence-plan-entry-transition-2026-10-02

Denmark issues new CTIS submission guidance for complex clinical trials and seasonal vaccine studies. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/danish-medicines-agency-complex-clinical-trial-seasonal-vaccine-ctis-guidance-2026-10-02

EMA sets 2026 year-end submission dates for Type I variations, helping regulatory teams plan upcoming filings. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/ema-type-i-variation-end-year-submission-dates-2026-10-01

Preregistration is moving to the centre of credible real-world evidence, with change histories making analytical decisions auditable. https://www.mattheneus.com/editorial/joint-rwe-transparency-statement-preregistration-change-history-2026-09-29 #HTA #RWE #RegulatoryAffairs

Germany’s G-BA found Lynkuet’s added benefit unproven in both menopause subgroups. Read the final resolution: https://www.mattheneus.com/editorial/g-ba-lynkuet-oasis3-final-resolution-2026-10-01 #HTA #RegulatoryAffairs #Pharma

Global regulators are aligning on non-animal evidence and batch release, with practical implications for medicines development. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/mhra-icmra-non-animal-methods-batch-release-global-statement-2026-10-01

UK approval extends Ocrevus access to children with relapsing-remitting multiple sclerosis. https://www.mattheneus.com/editorial/mhra-ocrevus-paediatric-rrms-access-work-sharing-operetta2-2026-09-21 #HTA #RegulatoryAffairs #Pharma

HAS rates zilucoplan prefilled pens ASMR V: no clinical added value over existing syringes.

https://www.mattheneus.com/editorial/has-zilbrysq-zilucoplan-prefilled-pen-asmr-v-restricted-reimbursement-2026-10-01

#HTA #RegulatoryAffairs #Pharma

FDA approves lirafugratinib on single-arm response-rate evidence, leaving HTA bodies to value a therapy with no comparative arm. https://www.mattheneus.com/editorial/fda-lyrfigtu-lirafugratinib-fgfr2-priority-review-approval-refocus-single-arm-2026-10-01 #HTA #RegulatoryAffairs

MHRA opens its 14-day assessment route to more Phase 1 patient studies, reshaping early UK trial timelines. https://www.mattheneus.com/editorial/mhra-14-day-assessment-stepwise-implementation-phase-1-eligibility-expansion-2026-09-30 #HTA #RegulatoryAffairs

Auto O2 switch with no clinician in the loop, classic design FMEA gap.

#DesignControl #RiskManagement #RegulatoryAffairs

EMA's women's health workshop set out ten priority actions, with sex-disaggregated data reporting at the centre. https://www.mattheneus.com/editorial/ema-womens-health-workshop-ten-priority-actions-sex-disaggregated-data-2026-09-30 #HTA #RegulatoryAffairs

A returning PBAC submission is priced against its own prior recommendation, a pattern consistent enough to plan for. https://www.mattheneus.com/editorial/pbac-repeat-submission-prior-recommendation-price-justification-pattern-2026-09-30 #HTA #RegulatoryAffairs

Oh good, two regulators writing the same homework assignment. Can't wait to do it twice. 🫠

#MDRCompliance #RegulatoryAffairs #FDACompliance

EU expert panel wants comparative studies on magnesium-alloy bioabsorbable bone screws: alloy equivalence cannot be assumed across devices. https://www.mattheneus.com/editorial/european-commission-expert-panel-magnesium-alloy-bioabsorbable-screws-alloy-equivalence-2026-09-29 #HTA #RegulatoryAffairs

EU expert panel demands comparative studies on magnesium-alloy bioabsorbable bone screws before alloy equivalence claims. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/european-commission-expert-panel-magnesium-alloy-bioabsorbable-screws-alloy-equivalence-2026-09-29