Fajar Dumadi, BSc
ISCT
Canada

Committee for Advanced Therapies (CAT)

Agendas for recent meetings

• Agenda for CAT workshop on gene editing on 16 September 2025 
  https://www.ema.europa.eu/en/documents/agenda/agenda-committee-advanced-therapies-cat-workshop-gene-editing_en.pdf 
• Agenda for the meeting on 8-9 October 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-8-9-october-2025_en.pdf   
• Agenda for the meeting on 5-7 November 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-5-7-november-2025_en.pdf
• Agenda for the meeting on 3-5 December 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-3-5-december-2025_en.pdf    

 
CAT quarterly highlights and approved ATMPs

• CAT quarterly highlights and approved ATMPs – December 2025
  https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-december-2025_en.pdf

Updates from Regulatory Agencies

EMA

• EMA confirms suspension of sickle cell disease medicine Oxbryta
  https://www.ema.europa.eu/en/news/ema-confirms-suspension-sickle-cell-disease-medicine-oxbryta    
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-october-2025 
• ICMRA Summit 2025: EMA concludes its two mandates as chair
  https://www.ema.europa.eu/en/news/icmra-summit-2025-ema-concludes-its-two-mandates-chair 
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-november-2025 
• EMA welcomes political agreement on new EU pharmaceutical legislation
  https://www.isctglobal.org/telegrafthub/blogs/fajar-dumadi/2025/12/12/ema-welcoming-the-landmark-political-agreement-on  
• First gene therapy to treat rare disease Wiskott-Aldrich syndrome
  https://www.ema.europa.eu/en/news/first-gene-therapy-treat-rare-disease-wiskott-aldrich-syndrome

MHRA

• Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI
  https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai  
• MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
  https://www.gov.uk/government/news/mhra-and-nice-invite-early-adopters-to-trial-accelerated-aligned-pathway-six-months-ahead-of-schedule 
• The new Innovative Licensing and Access Pathway welcomes first investigational products
  https://www.gov.uk/government/news/the-new-innovative-licensing-and-access-pathway-welcomes-first-investigational-products
• AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme
  https://www.gov.uk/government/news/ai-tools-that-could-detect-diseases-earlier-selected-for-next-phase-of-mhras-ai-airlock-programme 
• Major change for rare disease treatments on way, signals MHRA
  https://www.gov.uk/government/news/major-change-for-rare-disease-treatments-on-way-signals-mhra

Public Consultations

• MHRA - Rare therapies and UK regulatory considerations
  Consultation will begin in early 2026
  https://www.gov.uk/government/publications/rare-therapies-and-uk-regulatory-considerations 
• EMA – Draft guideline on non-inferiority and equivalence comparisons in clinical trials
  Consultation ends on 31 May 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-inferiority-equivalence-comparisons-clinical-trials_en.pdf 
• EMA - Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation
  Consultation ends on 31 January 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-non-human-primates-safety-testing-human-medicinal-products-opportunities-3rs-implementation_en.pdf 
• EMA - Reflection paper on patient experience data
  Consultation ends on 31 January 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-patient-experience-data_en.pdf 
• ICH – Q3E guideline for extractables and leachables
  Consultation ends on 18 December 2025
  https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q3e-guideline-extractables-leachables_en.pdf 
• ICH – Public Consultation – Guideline E20 for adaptive clinical trial design
  Consultation ends on 30 November 2025 
  https://www.gov.uk/government/consultations/consultation-on-the-international-council-for-harmonisation-guideline-e20-for-adaptive-clinical-trial-design/ich-e20-public-consultation

Events

Past Events

• HMA/EMA multi-stakeholder workshop on artificial intelligence – 20 November 2025
  https://www.ema.europa.eu/en/events/hma-ema-multi-stakeholder-workshop-artificial-intelligence
• ‘Setting standards that are trusted worldwide’ webinar – 9 October 2025
  Watch the webinar
• Minutes of the CAT meeting 12-14 August 2025 - written procedure https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-12-14-august-2025-written-procedure_en.pdf
• Minutes of the CAT meeting 16-18 July 2025
  https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-16-18-july-2025_en.pdf

Upcoming Events

• Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines – 28 November 2025
  https://www.ema.europa.eu/en/events/fifteenth-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicines 
• 15th industry stakeholder platform on research and development support – 4 December 2025 https://www.ema.europa.eu/en/events/15th-industry-stakeholder-platform-research-development-support

#Regulatory