Author:
Fajar Dumadi, BScInternational Society for Cell & Gene Therapy (ISCT)Canada
Committee of Advance Therapy (CAT)
· Minutes of the CAT meeting on 22-24 January 2025https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-22-24-january-2025_en.pdf
· Agenda for the meeting on 19-21 February 2025https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-19-21-february-2025_en.pdf
· Agenda for the meeting on 19-21 March 2025https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-19-21-march-2025_en.pdf
CAT quarterly highlights and approved ATMPs
· CAT quarterly highlights and approved ATMPshttps://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-february-2025_en.pdf
Updates from Regulatory Agencies
EMA
· EMA Management Board: highlights of March 2025 meetinghttps://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2025-meeting
· Unregulated advanced therapy medicinal products pose serious risks to healthhttps://www.ema.europa.eu/en/news/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health
· EMA Management Board elects new chair https://www.ema.europa.eu/en/news/ema-management-board-elects-new-chair
· New clinical trial map launched in the EUhttps://www.ema.europa.eu/en/news/new-clinical-trial-map-launched-eu
· First topical gene therapy treatment for dystrophic epidermolysis bullosahttps://www.ema.europa.eu/en/news/first-topical-gene-therapy-treatment-dystrophic-epidermolysis-bullosa
· Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-february-2025
· Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guidelinehttps://www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-scientific-guideline
· Clinical Trials Regulation becomes fully applicablehttps://www.ema.europa.eu/en/news/clinical-trials-regulation-becomes-fully-applicable
MHRA
· Decentralised manufacture hub: Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025https://www.gov.uk/government/collections/decentralised-manufacture-hub
· Minister visits MHRA to see cutting-edge science protecting patients and supporting the NHShttps://www.gov.uk/government/news/minister-visits-mhra-to-see-cutting-edge-science-protecting-patients-and-supporting-the-nhs
· New study shows MHRA collaboration with hospital DNA sequencing service cuts time to diagnose infectionshttps://www.gov.uk/government/news/new-study-shows-mhra-collaboration-with-hospital-dna-sequencing-service-cuts-time-to-diagnose-infections
· New chief executive appointed at MHRAhttps://www.gov.uk/government/news/new-chief-executive-appointed-at-mhra
· MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapieshttps://www.gov.uk/government/news/mhra-asks-for-views-on-proposed-guidance-to-support-the-safe-regulation-of-new-personalised-cancer-therapies
· UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathwayhttps://www.gov.uk/government/news/uk-patients-enabled-access-to-transformative-new-medicines-in-shortest-time-possible-via-new-integrated-innovative-licensing-and-access-pathway
Public Consultations
· ICH M11 Technical Specification – Updated step 2bConsultation ends on 22 April 2025https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m11-technical-specification-updated-step-2b_en.pdf
Events
Concluded events
· [Recording] MHRA Modular Manufacture and Point of Care Regulations Webinar – 28 January 2025https://www.youtube.com/watch?v=HhYGERVex8g
· Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders – 10 February 2025https://www.ema.europa.eu/en/events/regulation-eu-2024-568-questions-answers-clinic-human-industry-stakeholders
· European Medicines Agencies Network Strategy (EMANS) to 2028 webinar – 13 February 2025https://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 2025https://www.ema.europa.eu/en/events/act-eu-workshop-ich-e6-r3-principles-annex-1
Upcoming events
· Twelfth Industry Standing Group (ISG) meeting – 28 March 2025https://www.ema.europa.eu/en/events/twelfth-industry-standing-group-isg-meeting