News Hub

Author:

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

Committee of Advance Therapy (CAT)

Agendas for recent meetings

• Agenda for the meeting on 9-11 October 2024: https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-9-11-october-2024_en.pdf
• 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

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-may-july-2024_en.pdf

Updates from Regulatory Agencies

EMA

• Leqembi recommended for treatment of early Alzheimer’s disease: https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-november-2024
• European Shortages Monitoring Platform enables better monitoring of shortages in the EU: https://www.ema.europa.eu/en/news/european-shortages-monitoring-platform-enables-better-monitoring-shortages-eu

MHRA

• New Chair of the MHRA: https://www.gov.uk/government/news/new-chair-of-the-mhra
• Statutory Instrument laid in Parliament provides first regulatory framework of its kind that will transform the manufacture of innovative medicines at the point of patient care: https://www.gov.uk/government/news/statutory-instrument-laid-in-parliament-provides-first-regulatory-framework-of-its-kind-that-will-transform-the-manufacture-of-innovative-medicines-at?s=09
• The importance of giving patients a voice in the approval of new sickle cell treatment: https://www.gov.uk/government/case-studies/the-importance-of-giving-patients-a-voice-in-the-approval-of-new-sickle-cell-treatment

Public Consultations

• 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

• Sixth European Medicines Agency - EuropaBio bilateral meeting – 1 October 2024: https://www.ema.europa.eu/en/documents/other/highlights-sixth-ema-europabio-bilateral-meeting_en.pdf
• Scientific Symposium on Advanced Therapy Medicinal Products ‘Contribution, evolution, revolution’ – 10 October 2024: https://www.ema.europa.eu/en/events/scientific-symposium-advanced-therapy-medicinal-products-contribution-evolution-revolution
• Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meeting – 15 November 2024: https://www.ema.europa.eu/en/events/translating-innovation-access-atmps-3rd-eu-innovation-network-multi-stakeholder-meeting

Upcoming events

• LinkedIn Live session: Improving efficiency of approval process for new medicines in the EU: https://www.ema.europa.eu/en/events/linkedin-live-session-improving-efficiency-approval-process-new-medicines-eu
• Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities: https://www.ema.europa.eu/en/events/training-session-patients-consumers-healthcare-professionals-involved-medicine-regulatory-activities
• Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system: https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-46

#Regulatory