News Hub

Fajar Dumadi, BSc 
ISCT
Canada

Committee for Advanced Therapies (CAT)

Agendas for Recent Meetings

• 11-13 May 2026
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-11-13-may-2026_en.pdf 
• 15-17 April 2026
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-15-17-april-2026_en.pdf
  
• 18-20 March 2026 
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-18-20-march-2026_en.pdf
  

CAT Quarterly Highlights and Approved ATMPs

• CAT quarterly highlights and approved ATMPs – March 2026
  https://www.ema.europa.eu/system/files/documents/committee-report/2026-03-cat-quarterly-highlights-approved-atmps-dec-2025-feb-2026-en.pdf

Updates from Regulatory Agencies

EMA

• EU recommendations for 2026/2027 seasonal flu vaccine composition
  https://www.ema.europa.eu/en/news/eu-recommendations-2026-2027-seasonal-flu-vaccine-composition
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-may-2026
  
• New medicine for two types of pulmonary fibrosis
  https://www.ema.europa.eu/en/news/new-medicine-two-types-pulmonary-fibrosis
  
• First oral GLP-1 treatment for weight management
  https://www.ema.europa.eu/en/news/first-oral-glp-1-treatment-weight-management
  
• First medicine to treat rare uncontrolled growth of body tissues
  https://www.ema.europa.eu/en/news/first-medicine-treat-rare-uncontrolled-growth-body-tissues
  
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2026
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-april-2026
  
• New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome
  https://www.ema.europa.eu/en/news/new-medicine-reduce-triglycerides-adults-familial-chylomicronaemia-syndrome
  

MHRA

• Landmark new plans bring treatments for rare diseases a step closer
  https://www.gov.uk/government/news/landmark-new-plans-bring-treatments-for-rare-diseases-a-step-closer 
• MHRA approves beremagene geperpavec (Vyjuvek) for the treatment of dystrophic epidermolysis bullosa
  https://www.gov.uk/government/news/mhra-approves-beremagene-geperpavec-vyjuvek-for-the-treatment-of-dystrophic-epidermolysis-bullosa 
• MHRA consults on new regulatory framework to make UK a global leader in rare disease therapy development
  https://www.gov.uk/government/news/mhra-consults-on-new-regulatory-framework-to-make-uk-a-global-leader-in-rare-disease-therapy-development 
• MHRA opens UK-wide consultation on redefining gene therapies
  https://www.gov.uk/government/news/mhra-opens-uk-wide-consultation-on-redefining-gene-therapies 
• Single-dose 7.2mg semaglutide (Wegovy) pen approved to treat adult patients with obesity
  https://www.gov.uk/government/news/single-dose-72mg-semaglutide-wegovy-pen-approved-to-treat-adult-patients-with-obesity 
• Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
  https://www.gov.uk/government/news/enflonsia-clesrovimab-cfor-approved-to-prevent-rsv-in-newborns-and-infants

Public Consultations

• EMA - Draft guideline on non-inferiority and equivalence comparisons in clinical trials
  Consultation closes on 31 May 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-inferiority-equivalence-comparisons-clinical-trials_en.pdf 
• MHRA - Consultation on the regulation of Gene therapy medicinal products
  Consultation closes on 22 June 2026
  https://www.gov.uk/government/consultations/consultation-on-the-regulation-of-gene-therapy-medicinal-products 
• EMA – Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
  Consultation closes on 30 June 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-proof-concept-data-support-development-anti-cancer-medicinal-products-paediatric-patients_en.pdf 
• EMA - Guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis
  Consultation closes on 31 August 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-cystic-fibrosis_en.pdf
• EMA - Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
  Consultation closes on 30 September 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-amyotrophic-lateral-sclerosis_en.pdf

Events

Past Events

• 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan – 31 March 2026
  https://www.ema.europa.eu/en/events/3rs-working-party-3rswp-stakeholder-meeting-public-session-2026-2028-work-plan
• 16th Industry Standing Group (ISG) meeting – 31 March 2026
  https://www.ema.europa.eu/en/events/16th-industry-standing-group-isg-meeting
• ACT EU webinar on draft guidance on the conduct of clinical trials during public health emergencies – 8 April 2026
  https://www.ema.europa.eu/en/events/act-eu-webinar-draft-guidance-conduct-clinical-trials-during-public-health-emergencies

Upcoming Events

• EMA workshop on the challenges in drug development, regulation and clinical practice in immune thrombocytopenia – 30 June 2026
  https://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-immune-thrombocytopenia