Fajar Dumadi, BSc 
International Society for Cell & Gene Therapy (ISCT)
Canada

Committee for Advanced Therapies (CAT)

Agendas for Recent Meetings

• Agenda of the CAT meeting 15-17 July 2026
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-15-17-july-2026_en.pdf 
• Agenda of the CAT meeting 17-19 June 2026
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-17-19-june-2026_en.pdf 
• Agenda for the meeting on 11-13 May 2026
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-11-13-may-2026_en.pdf 

CAT Quarterly Highlights and Approved ATMPs

• CAT quarterly highlights and approved ATMPs – June 2026 
  https://www.ema.europa.eu/system/files/documents/committee-report/cat-quarterly-highlights-approved-atmps-june-2026-en.pdf 
• 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

• First oral medicine targeting interleukin-23 receptor recommended for plaque psoriasis
  https://www.ema.europa.eu/en/news/first-oral-medicine-targeting-interleukin-23-receptor-recommended-plaque-psoriasis 
• EMA and EISMEA boost cooperation to accelerate health innovations
  https://www.ema.europa.eu/en/news/ema-eismea-boost-cooperation-accelerate-health-innovations 
• EMA fast-tracks review of a medicine for metastatic pancreatic cancer
  https://www.ema.europa.eu/en/news/ema-fast-tracks-review-medicine-metastatic-pancreatic-cancer 
• EMA recommends revoking marketing authorisation for Tavneos
  https://www.ema.europa.eu/en/news/ema-recommends-revoking-marketing-authorisation-tavneos 
• EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines
  https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines
• EMA, AMA and African regulatory authorities join forces on Ebola outbreak response
  https://www.ema.europa.eu/en/news/ema-ama-african-regulatory-authorities-join-forces-ebola-outbreak-response 

MHRA

• Pioneering AI health innovations regulatory sandbox launched
  https://www.gov.uk/government/news/pioneering-ai-health-innovations-regulatory-sandbox-launched 
• Unique liaison programme set to reinforce close collaboration between MHRA and FDA
  https://www.gov.uk/government/news/unique-liaison-programme-set-to-reinforce-close-collaboration-between-mhra-and-fda 
• Update on the PATHWAYS clinical trial
  https://www.gov.uk/government/news/update-on-the-pathways-clinical-trial 
• MHRA approves world's first lower-carbon beclometasone inhalers for patients with asthma
  https://www.gov.uk/government/news/mhra-approves-worlds-first-lower-carbon-beclometasone-inhalers-for-patients-with-asthma 
• MHRA launches AI sandbox to accelerate medicines development and improve safety
  https://www.gov.uk/government/news/mhra-launches-ai-sandbox-to-accelerate-medicines-development-and-improve-safety 

Public Consultations

• WHO - Guidelines on procedures and data requirements for changes to approved vaccines and biotherapeutics
  Consultation closes on 25 September 2026
  https://cdn.who.int/media/docs/default-source/biologicals/bs-documents-(ecbs)/guidelines-2026/who-guidelines-on-changes-to-approved-vaccines-and-biotherapeutics_bs-final_8july2026.pdf?sfvrsn=dc86305c_3 
• WHO - Global Strategy on Donation and Transplantation
  Consultation closes on 31 August 2026
  https://cdn.who.int/media/docs/default-source/transplantation/global-strategy-on-donation-and-transplantation---draft-1-(26-june-2026).pdf?sfvrsn=788f72c2_1&download=true  
• 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

• 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
  

Upcoming Events

• Workshop on advancing proof-of-concept data in paediatric oncology drug development
  https://www.ema.europa.eu/en/events/workshop-advancing-proof-concept-data-paediatric-oncology-drug-development 
• Joint European Commission (EC) / European Medicines Agency (EMA) multi-stakeholder workshop on regulatory sandbox
  https://www.ema.europa.eu/en/events/joint-european-commission-ec-european-medicines-agency-ema-multi-stakeholder-workshop-regulatory-sandbox 
• Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) multistakeholder workshop on real-world data collection in Duchenne muscular dystrophy – 25 September 2026
  https://www.ema.europa.eu/en/events/joint-heads-medicines-agencies-hma-european-medicines-agency-ema-multistakeholder-workshop-real-world-data-collection-duchenne-muscular-dystrophy