News Hub

Fajar Dumadi, BSc
ISCT
Canada

Committee for Advanced Therapies (CAT)

Agendas for recent meetings

• Agenda for the meeting on 18-20 March 2026 
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-18-20-march-2026_en.pdf 
• Agenda for the meeting on 18-20 February 2026 
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-18-20-february-2026_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

• New PRIME tools to accelerate development of medicines in the EU
  https://www.ema.europa.eu/en/news/new-prime-tools-accelerate-development-medicines-eu 
• New guidance on the conduct of clinical trials during public health emergencies in the EU
  https://www.ema.europa.eu/en/news/new-guidance-conduct-clinical-trials-during-public-health-emergencies-eu 
• New medicine to treat paediatric low-grade glioma
  https://www.ema.europa.eu/en/news/new-medicine-treat-paediatric-low-grade-glioma
• First treatment for rare thymidine kinase 2 deficiency
  https://www.ema.europa.eu/en/news/first-treatment-rare-thymidine-kinase-2-deficiency
• New medicine to treat chronic graft-versus-host disease
  https://www.ema.europa.eu/en/news/new-medicine-treat-chronic-graft-versus-host-disease
• EMA starts review of Tavneos, a medicine for rare autoimmune diseases GPA and MPA
  https://www.ema.europa.eu/en/news/ema-starts-review-tavneos-medicine-rare-autoimmune-diseases-gpa-mpa
• First immunotherapy-based treatment recommended for advanced anal cancer
  https://www.ema.europa.eu/en/news/first-immunotherapy-based-treatment-recommended-advanced-anal-cancer
• Ilona Reischl re-elected as chair of Committee for Advanced Therapies
  https://www.ema.europa.eu/en/news/ilona-reischl-re-elected-chair-committee-advanced-therapies  

    
MHRA

• Shaping the Future of Healthcare Through Global Regulatory Innovation
  https://www.gov.uk/government/news/shaping-the-future-of-healthcare-through-global-regulatory-innovation 
• MHRA action boosts drive to phase out animal testing
  https://www.gov.uk/government/news/mhra-action-boosts-drive-to-phase-out-animal-testing 
• Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process
  https://www.gov.uk/government/news/patients-to-get-new-medicines-up-to-six-months-sooner-under-new-joint-mhra-nice-approval-process 
• MHRA statement on Pathways clinical trial
  https://www.gov.uk/government/news/mhra-statement-on-pathways-clinical-trial 
• MHRA approves imlunestrant tosylate (Inluriyo) - a new treatment for breast cancer
  https://www.gov.uk/government/news/mhra-approves-imlunestrant-tosylate-inluryo-a-new-treatment-for-breast-cancer
• Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older
  https://www.gov.uk/government/news/brensocatib-licensed-as-the-first-medicine-specifically-designed-to-treat-non-cystic-fibrosis-bronchiectasis-in-patients-12-years-and-older  

Public Consultations

• BP – 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/html/550
• BP – 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/html/550 
• 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
• EMA – Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development
  Consultation closes on 30 April 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf  
• EMA – Draft guidance on the conduct of clinical trials during public health emergencies
  Consultation closes on 30 April 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guidance-conduct-clinical-trials-during-public-health-emergencies_en.pdf 
• EMA – Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
  Consultation closes on 30 June 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-proof-concept-data-support-development-anti-cancer-medicinal-products-paediatric-patients_en.pdf 
• Guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis
  Consultation closes on 31 August 2026
  https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-cystic-fibrosis_en.pdf 

Events

Past events

• MHRA webinar on Implementing the new UK Clinical Trials regulations – 12 March 2026
  https://www.youtube.com/watch?v=17cDN_vH42g 
• 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
• 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 

Upcoming events

• 3Rs Working Party (3RsWP) stakeholder meeting - Public session on the 2026-2028 work plan – 31 March 2026
  https://www.ema.europa.eu/en/events/3rs-working-party-3rswp-stakeholder-meeting-public-session-2026-2028-work-plan
• 16th Industry Standing Group (ISG) meeting – 31 March 2026
  https://www.ema.europa.eu/en/events/16th-industry-standing-group-isg-meeting
• ACT EU webinar on draft guidance on the conduct of clinical trials during public health emergencies – 8 April 2026
  https://www.ema.europa.eu/en/events/act-eu-webinar-draft-guidance-conduct-clinical-trials-during-public-health-emergencies 
• EMA workshop on the challenges in drug development, regulation and clinical practice in immune thrombocytopenia – 30 June 2026
  https://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-immune-thrombocytopenia