News Hub

Contributor(s):

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

Committee for Advanced Therapies (CAT)

Agendas for recent meetings

• Agenda for the meeting on 14-16 May 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-14-16-may-2025_en.pdf
• Agenda for the meeting on 11-13 June 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-11-13-june-2025_en.pdf
  
• 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
  

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 stem cell therapy to treat patients with blood cancers
  https://www.ema.europa.eu/en/news/new-stem-cell-therapy-treat-patients-blood-cancers
• First treatment against liver scarring caused by a type of fatty liver disease
  https://www.ema.europa.eu/en/news/first-treatment-against-liver-scarring-caused-type-fatty-liver-disease
  
• EMA Paediatric Committee elects Sabine Scherer as its new chair
  https://www.ema.europa.eu/en/news/ema-paediatric-committee-elects-sabine-scherer-its-new-chair
  
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-june-2025
  
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-june-2025
  
• Call for members – Public call for expression of interest for experts to become members of the European Medicines Agency's scientific advisory group on immune and inflammatory diseases.
  Those interested to become members of this scientific advisory group should apply before 17 September 2025. 
  https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/scientific-advisory-group-immune-inflammatory-diseases
  

MHRA

• Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
  https://www.gov.uk/government/news/cutting-edge-personalised-treatments-made-while-you-wait-will-deliver-specialised-care-to-patients-more-quickly
• Five non-executive directors reappointed to the Medicines and Healthcare products Regulatory Agency Board
  https://www.gov.uk/government/news/five-non-executive-directors-reappointed-to-the-medicines-and-healthcare-products-regulatory-agency-board
  
• UK MHRA leads safe use of AI in healthcare as first country in new global network
  https://www.gov.uk/government/news/uk-mhra-leads-safe-use-of-ai-in-healthcare-as-first-country-in-new-global-network
  
• Fast, Expert and Open – how the MHRA is poised to become a global leader in risk-proportionate regulation
  https://www.gov.uk/government/news/fast-expert-and-open-how-the-mhra-is-poised-to-become-a-global-leader-in-risk-proportionate-regulation
  

Public Consultations

• ICH – Public Consultation - E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
  Consultation ends on 5 September 2025
  https://database.ich.org/sites/default/files/ICH_E21EWG_Step2_Draft_Guideline_2025_0514.docx
• BP – Public Consultation – Newly Published Draft Texts
  Consultation ends on 30 September 2025
  https://www.pharmacopoeia.com/content/html/529
  
• 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

• 14th industry stakeholder platform on research and development support – 3 July 2025
  https://www.ema.europa.eu/en/events/14th-industry-stakeholder-platform-research-development-support
• Annual British Pharmacopoeia Webinar – 10 July 2025
  https://www.pharmacopoeia.com/content/html/519
  

Upcoming 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