News Hub

Fajar Dumadi, BSc
ISCT
Canada

Committee for Advanced Therapies (CAT)

Agendas for recent meetings

• Agenda for the meeting on 16-18 July 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-16-18-july-2025_en.pdf
  
• Agenda for the meeting on 10-12 September 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-10-12-september-2025_en.pdf
  

CAT quarterly highlights and approved ATMPs

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

Updates from Regulatory Agencies

EMA

• New targets for clinical trials in Europe
  https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe
• Management Board formally approved renewal of Executive Director’s mandate
  https://www.ema.europa.eu/en/news/management-board-formally-approves-renewal-executive-directors-mandate
• EMA and WHO mark ten years of collaboration to advance global access to medicines
  https://www.ema.europa.eu/en/news/ema-who-mark-ten-years-collaboration-advance-global-access-medicines

MHRA

• MHRA designated as WHO-Listed Authority: a milestone for UK life sciences and global health
  https://www.gov.uk/government/news/mhra-designated-as-who-listed-authority-a-milestone-for-uk-life-sciences-and-global-health 
• MHRA launches Route B notification pilot as part of clinical trials regulations rollout
  https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout
• Looking to our future: reflections on the strategic choices ahead for the MHRA
  https://www.gov.uk/government/news/looking-to-our-future-reflections-on-the-strategic-choices-ahead-for-the-mhra

Public Consultations

• ICH – M4Q(R1) Draft Guideline  
  Consultation ends on 24 October 2025
  https://database.ich.org/sites/default/files/ICH%20M4Q%28R2%29_Draft_Guideline_2025_0514.docx  
• EMA – Public Consultation – Draft concept paper on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making
  Consultation ends on 31 October 2025 
  https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-reflection-paper-use-external-controls-evidence-generation-regulatory-decision-making_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

• Committee for Medicinal Products for Human Use (CHMP) Meet– 15-18 September 2025
  https://www.ema.europa.eu/en/events/committee-medicinal-products-human-use-chmp-15-18-september-2025 
• Committee for Advanced Therapies (CAT) workshop on gene editing – 16 September 2025
  https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-workshop-gene-editing

Upcoming events

• European Platform for Regulatory Science Research meeting September 2025 – 29 September 2025
  https://www.ema.europa.eu/en/events/european-platform-regulatory-science-research-meeting-september-2025
• Workshop on the use of external controls for evidence generation in regulatory decision-making – 3 November 2025
  https://www.ema.europa.eu/en/events/workshop-use-external-controls-evidence-generation-regulatory-decision-making
• 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