News Hub

Contributor(s):

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

Alejandro Barquero, MPharm, MSc
Almirall
Spain

Committee of Advance Therapy (CAT)

Agendas for recent meetings

• Agenda for the meeting on 6-8 November 2024
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-6-8-november-2024_en.pdf
• Agenda for the meeting on 4-6 December 2024
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-4-6-december-2024_en.pdf
• Agenda for the meeting on 22-24 January 2025
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-22-24-january-2025_en.pdf

CAT quarterly highlights and approved ATMPs

• CAT quarterly highlights and approved ATMPs
  https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-november-2024_en.pdf 

Updates from Regulatory Agencies

EMA

• CAT work plan 2025
  https://www.ema.europa.eu/en/documents/work-programme/committee-advanced-therapies-cat-work-plan-2025_en.pdf 
• CHMP work plan 2025
  https://www.ema.europa.eu/en/documents/work-programme/chmp-work-plan-2025_en.pdf 
• New EU rules for health technology assessments become effective
  https://www.ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective 
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024
  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-december-2024 
• Recommendations on eligibility to PRIME scheme – Adopted at the CHMP meeting of 9-12 December 2024
  https://www.ema.europa.eu/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-9-12-december-2024_en.pdf

MHRA

• New MHRA Chair Anthony Harnden outlines priorities as he starts role
  https://www.gov.uk/government/news/new-mhra-chair-anthony-harnden-outlines-priorities-as-he-starts-role
• MHRA Real-World Evidence Scientific Dialogue Programme
  https://www.gov.uk/government/publications/mhra-real-world-evidence-scientific-dialogue-programme  
• Patient Involvement Strategy: an assessment of progress
  https://www.gov.uk/government/publications/patient-involvement-strategy-an-assessment-of-progress
• MHRA performance data for assessment of clinical trials and established medicines
  https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines

Public Consultations

• MHRA - Consultation - Draft guidance on individualised mRNA cancer immunotherapies
  Consultation ends on 31 March 2025
  https://www.gov.uk/government/consultations/draft-guidance-on-individualised-mrna-cancer-immunotherapies
• International Council for Harmonisation ICH M15 General Principles for Model-Informed Drug Development (MIDD) guideline
  Consultation ends on 31 March 2025
  https://www.gov.uk/government/consultations/consultation-on-the-international-council-for-harmonisation-ich-m15-guideline-for-model-informed-drug-development-midd 
• International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2
  Consultation ends on 14 February 2025
  https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Annex%202_Step2_DraftGuideline_2024_1024_0.pdf

Events

Past events

• Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion – 14 January 2025
  https://www.ema.europa.eu/en/events/conversations-cancer-cervical-cancer-treatment-innovation-collaborative-discussion
• EMA press briefing on human medicines in 2024 – 16 January 2025
  https://www.ema.europa.eu/en/events/ema-press-briefing-human-medicines-2024

 Upcoming events

• Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders – 10 February 2025
  https://www.ema.europa.eu/en/events/regulation-eu-2024-568-questions-answers-clinic-human-industry-stakeholders  
• MHRA GCP & Laboratories Symposium – 11-12 February 2025
  https://mhragcp-labs.co.uk/home#home 
• European Medicines Agencies Network Strategy (EMANS) to 2028 webinar – 13 February 2025
  https://www.ema.europa.eu/en/events/european-medicines-agencies-network-strategy-emans-2028-webinar  
• ACT EU workshop on ICH E6 R3 (principles and Annex 1) – 19-20 February 2025
  https://www.ema.europa.eu/en/events/act-eu-workshop-ich-e6-r3-principles-annex-1  
• Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations – 13 March 2025
  https://www.ema.europa.eu/en/events/qa-clinic-web-based-electronic-application-form-eaf-functionalities-caps-non-caps-variations#event-summary-73235