#regulatoryaffairs — Public Fediverse posts

Conditional reimbursement can turn comparator uncertainty into a concrete evidence and risk-sharing plan. https://www.mattheneus.com/editorial/aotmit-tevimbra-tislelizumab-conditional-reimbursement-risk-sharing-2026-10-07 #HTA #Pharma #RegulatoryAffairs

France’s early-access refusal for Pyrukynd in sickle cell disease shows how trial design, comparator relevance and uncertainty shape access decisions. https://www.mattheneus.com/editorial/has-pyrukynd-mitapivat-sickle-cell-early-access-refusal-riseup-2026-10-01 #HTA #Pharma #RegulatoryAffairs

Elektronische Packungsbeilage (ePI) ab 2026 Pflicht? Nein.

Der tatsächliche Zeitplan im EU-Pharmapaket:
–> 12/2025: politische Einigung
–> Sommer 2026: formale Annahme erwartet
–> ca. 2028: Pflicht für neue Zulassungen
–> ca. 2031: Pflicht für Bestandsprodukte

Papier verschwindet nicht. Die Mitgliedstaaten entscheiden selbst, und Patient:innen behalten das Recht auf ein kostenloses Papierexemplar.

Zeitplan, Pilotprojekte und Checkliste für 2026:
https://alugha.com/cms/epi-electronic-product-information-eu-timeline/

#ePI #Pharma #Packungsbeilage #EUPharmapaket #RegulatoryAffairs

Germany's G-BA left the magnitude of Zynyz's benefit open after a single-arm Merkel cell carcinoma study, highlighting the decision limits created by comparative evidence gaps. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/g-ba-zynyz-mcc-benefit-extent-single-arm-podium201-2026-10-01

Europe’s joint clinical assessment framework is moving into medical devices, with the European Commission selecting its first two technologies for assessment. https://www.mattheneus.com/editorial/european-commission-first-medical-device-jca-sapien-m3-highlife-mitral-valves-2026-10-06 #HTA #RegulatoryAffairs #Pharma

WHO’s adolescent obesity guideline sets a six-month multimodal gateway before pharmacotherapy, shaping evidence expectations and access pathways. https://www.mattheneus.com/editorial/who-adolescent-obesity-guideline-six-month-multimodal-pharmacotherapy-pathway-2026-10-07 #HTA #HealthEconomics #RegulatoryAffairs

The UK approval of Korjuny brings randomized drainage-control evidence into focus for malignant ascites. https://www.mattheneus.com/editorial/mhra-korjuny-catumaxomab-malignant-ascites-randomised-paracentesis-2026-10-02 #HTA #RegulatoryAffairs #Pharma

How should staged access to healthcare AI connect with economic appraisal? The UK's 44-point plan makes that question operational. https://www.mattheneus.com/editorial/uk-healthcare-artificial-intelligence-staged-access-economic-appraisal-2026-10-06 #HTA #HealthEconomics #RegulatoryAffairs