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#surveys #evidencestrategy #therabusiness #regulatoryaffairs

GB would get enabling powers for its own device licensing route under Health Bill amendments. https://www.mattheneus.com/editorial/mhra-health-bill-amendments-device-licensing-information-sharing-2026-09-01 #HTA #RegulatoryAffairs

MEXICO COFEPRIS Alert: 4 Falsified Drugs - What It Means for Brands #COFEPRIS #MexicoSupplements #RegulatoryAffairs

30 min slides, 25 min "but here's why OUR gap-analysis template is better." Actual learning: the 5 min Q&A. ASQ chapters and notified body workshops beat vendor pitch decks every time. Anyone else ditching these? 🫠📋 #ISO13485 #MedTech #QualityManagement #RegulatoryAffairs #CAPA #qmsWrapper

FDA approves apitegromab as an add-on in nonambulatory spinal muscular atrophy: the SAPPHIRE evidence lineage now has to carry an add-on question through HTA. https://www.mattheneus.com/editorial/fda-apitegromab-isembyld-nonambulatory-sma-add-on-approval-sapphire-2026-09-28 #HTA #RegulatoryAffairs

Poland's AOTMiT opens a seven-day tariff consultation on robotic and laparoscopic radical prostatectomy. https://www.mattheneus.com/editorial/aotmit-robotic-surgery-laparoscopic-prostatectomy-device-cost-tariff-consultation-2026-09-28 #HTA #HealthEconomics #RegulatoryAffairs

Wrapper's Mapper, one quality event, every affected doc traced automatically. Change control should have worked like this from the start. Genuinely curious how it handles a real backlog with linked complaints.

#RegulatoryAffairs #ChangeControl #CAPA

Poland's AOTMiT refuses reimbursement for oral edaravone imported for amyotrophic lateral sclerosis. https://www.mattheneus.com/editorial/aotmit-radicut-edaravone-oral-suspension-als-targeted-import-non-recommendation-2026-09-28 #HTA #RegulatoryAffairs #HealthEconomics

Denmark’s medicines agency sets a 28 September cutover for Europe’s new clinical-trial safety reporting module. https://www.mattheneus.com/editorial/danish-medicines-agency-ctis-annual-safety-report-module-cutover-2026-09-28 #HTA #RegulatoryAffairs #Pharma

PBAC recommends Clozaril orally disintegrating tablets across five strengths, expanding formulation choice. https://www.mattheneus.com/editorial/pbac-clozaril-orally-disintegrating-tablets-five-strengths-listing-2026-08-21 #HTA #Pharma #RegulatoryAffairs

Germany opens a migraine-acupuncture consultation around a three-trial evidence base. https://www.mattheneus.com/editorial/g-ba-acupuncture-migraine-prevention-consultation-three-trial-evidence-2026-09-24 #HTA #EvidenceSynthesis #RegulatoryAffairs

Poland's HTA agency flags a comparator gap in Tevimbra's nasopharyngeal cancer submission. https://www.mattheneus.com/editorial/aotmit-tevimbra-nasopharyngeal-carcinoma-comparator-gap-assessment-2026-09-25 #HTA #Pharma #RegulatoryAffairs

WHO recommends international scheduling for three synthetic drugs and keeps coca leaf controlled. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/who-ecdd-48-synthetic-opioid-cannabinoid-coca-scheduling-2026-09-24

Rare-disease trials need a defensible statistical file before enrolment starts. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/fda-rise-rare-disease-trial-statistical-design-file-2026-09-29

WHO’s first target product profiles for novel male contraceptives set clear efficacy and development thresholds. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/who-novel-male-contraceptive-target-product-profiles-efficacy-thresholds-2026-09-22

Intuitive pushing cardiac robotics into europe via ce mark is genuinely big news. But the constraint nobody puts in the press release is surgeon training throughput. Takes years, not quarters.

#TechnicalFile #RegulatoryAffairs #MDRCompliance

WHO has set evidence thresholds for five contraceptive options, clarifying the path from emerging evidence to global guidance. #HTA #EvidenceSynthesis #RegulatoryAffairs https://www.mattheneus.com/editorial/who-expanding-contraceptive-options-five-evidence-thresholds-2026-09-23

Germany opens written comments on cardiac MRI for coronary heart disease, creating a timely opportunity to shape the evidence discussion. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/germany-cardiac-magnetic-resonance-imaging-coronary-heart-disease-comment-procedure-2026-09-24

KHEIRON cleared with a patient-specific 510(k). So every spine case is now its own design change event. My DHF filed a deviation. 🫠

#DesignControl #ChangeControl #RegulatoryAffairs