Fajar Dumadi, BSc
ISCT
Canada

Committee for Advanced Therapies (CAT)

Agendas for recent meetings

• 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
• Agenda for the meeting on 21-23 January 2026 
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-21-23-january-2026_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 welcomes political agreement on new EU pharmaceutical legislation
  https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation 
• New medicine to treat non-muscle invasive bladder cancer
  https://www.ema.europa.eu/en/news/new-medicine-treat-non-muscle-invasive-bladder-cancer 
  
• Human medicines in 2025
  https://www.ema.europa.eu/en/news/human-medicines-2025 
  
• EMA and FDA set common principles for AI in medicine development
  https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0
  
• EMA Management Board: highlights of December 2025 meeting
  https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2025-meeting 
  

MHRA

• Guidance - International Council for Harmonisation (ICH) E6R3 Annotations
  https://www.gov.uk/government/publications/international-council-for-harmonisation-ich-e6r3-annotations
• MHRA welcomes Professor Jonathan Benger CBE as new CEO of NICE
  https://www.gov.uk/government/news/mhra-welcomes-professor-jonathanbenger-cbe-as-new-ceo-of-nice
  
• UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies
  https://www.gov.uk/government/news/uk-and-singapore-launch-a-regulatory-innovation-corridor-to-speed-up-access-to-breakthrough-health-technologies
  
• Open call for evidence - Regulation of AI in Healthcare
  https://www.gov.uk/government/calls-for-evidence/regulation-of-ai-in-healthcare 
  
  

Public Consultations

• British Pharmacopoeia – Draft Guidance on Characterisation of the Capsid Particle Population in rAAV Products: Determination of Vector Genome Identity, Integrity and Encapsidated DNA Impurities
  Consultation closes on 27 March 2026
  https://www.pharmacopoeia.com/content/file/Characterisation-of-the-Capsid-Particle-Population-in-rAAV-Products-Determination-of-Vector-Genome-Identity-Integrity-and-Encapsidated-DNA-Impurities_public-consultation.pdf 
• British Pharmacopoeia – Draft Guidance on Characterisation of the Capsid Particle Population in rAAV Products: Capsid Protein Characterisation
  Consultation closes on 27 March 2026
  https://www.pharmacopoeia.com/content/file/Characterisation-of-the-Capsid-Particle-Population-in-rAAV-Products-Capsid-Protein-Characterisation-guidance_public-consultation_.pdf
  
• ICH – Draft Guideline on General Considerations for Patient Preference Studies 
  Consultation closes on 16 April 2026
  https://database.ich.org/sites/default/files/ICH_E22_Step2_draftGuideline_Assembly_Endorsed_FINAL_2025_1119.pdf
  
  

Events

Past Events

• 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
• 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 

Upcoming Events

• Webinar for stakeholder engagement on the new draft guideline on general considerations for patient preference studies (ICH E22) - 6 February 2026
  https://www.ema.europa.eu/en/events/webinar-stakeholder-engagement-new-draft-guideline-general-considerations-patient-preference-studies-ich-e22 
• Webinar on the use of platform technologies in the non-clinical and clinical domains – 2 March 2026
  https://www.ema.europa.eu/en/events/webinar-use-platform-technologies-non-clinical-clinical-domains