News Hub

Laura Mendieta, PhD 
Asphalion
Spain

Committee of Advance Therapy (CAT)

Minutes of the meetings

• Minutes for the meeting on 17-19 April 2024
  https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-17-19-april-2024_en.pdf
• Minutes for the meeting on 13-15 March 2024
  https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-13-15-march-2024_en.pdf

Agendas for upcoming meetings

• Agenda for the meeting on 19-21 June 2024
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-19-21-june-2024_en.pdf
• Agenda for the meeting on 17-19 July 2024
  https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-17-19-july-2024_en.pdf

Updates from Regulatory Agencies

Updates from the EMA

• Two new advice pilots to improve clinical trials in Europe – 10 June 2024
  https://www.ema.europa.eu/en/news/two-new-advice-pilots-improve-clinical-trials-europe
• CTIS Sponsor Handbook – Updated in June 2024
  https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_en.pdf
• CTIS presentation: Revised CTIS transparency rules and new version of the public portal
  https://www.ema.europa.eu/en/documents/presentation/presentation-revised-ctis-transparency-rules-new-version-public-portal_en.pdf
• CTIS newsflash – 12 July 2024
  https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-12-july-2024_en.pdf
• CTIS newsflash – 26 July 2024
  https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-26-july-2024_en.pdf
• Application of the “Revised transparency rules” for CTIS
  https://www.ema.europa.eu/en/documents/other/revised-ctis-transparency-rules_en.pdf
• New Fee Regulation working arrangements
  https://www.ema.europa.eu/en/documents/other/new-fee-regulation-working-arrangements_en.pdf
• Draft “Guideline on the Development and Manufacture of Oligonucleotides”
  https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-manufacture-oligonucleotides_en.pdf

Updates from the MHRA

• Update on the guidance “International Recognition Procedure”
  https://www.gov.uk/government/publications/international-recognition-procedure#full-publication-update-history

Events

Past Events

• EMA workshop on the challenges in drug development, regulation, and clinical practice in hemoglobinopathies – 01 July 2024
  https://www.ema.europa.eu/en/events/ema-workshop-challenges-drug-development-regulation-clinical-practice-hemoglobinopathies

• Twelfth meeting of the industry stakeholder platform on research and development support
  https://www.ema.europa.eu/en/events/twelfth-meeting-industry-stakeholder-platform-research-development-support

• Clinical Trials Information System (CTIS): Walk-in clinic - July 2024
  https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-july-2024

Upcoming events

• Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU– 11 September 2024
  https://www.ema.europa.eu/en/events/clinical-trials-regulation-ctr-collaborate-stakeholder-meeting-supported-act-eu

• Joint HMA/EMA multi-stakeholder workshop on pharmacogenomics – 25 September 2024
  https://www.ema.europa.eu/en/events/joint-hma-ema-multi-stakeholder-workshop-pharmacogenomics