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EU LRA Watchdog - February 2024


Laura Mendieta, PhD - Senior Scientific and RA Officer Project Manager
ISCT Legal and Regulatory Affairs Committee: Europe 
Barcelona, Spain

Alejandro Barquero, MPharm, MSc - CMC Manager
ISCT Legal and Regulatory Affairs Committee: Europe
DanausGT Biotechnology Ltd.
Madrid, Spain


Committee of Advance Therapy (CAT)

Minutes of the meetings

  • Minutes for the meeting on 6-8 December 2023

Agendas for upcoming meetings

  • Agenda for the meeting on 14-16 January 2024

Updates from Regulatory Agencies

Updates from the EMA

  • CTIS newsflash – 24th November 2023

  • Relaunched EMA website – 5th December 2023

  • The EU Pharmaceutical Reform - Awareness session for SMEs – 6th December 2023

  • Frequently asked questions on medicinal products development and assessment involving companion diagnostic (CDx) – 6th December 2023

  • Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines – 8th December 2023

Close collaboration between medicines regulators worldwide is paving the way towards the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS). The goal is to ensure patients can benefit from a continuous supply of life-saving medicines in a world where changing manufacturing processes, technological innovations and complex supply chains can, among other factors, affect the availability of medicines.

  • CHMP positive opinion: Casvegy (GTMP)

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Casgevy, intended for the treatment of transfusiondependent βthalassemia (TDT) and sickle cell disease (SCD) following the assessment by the Committee for Advanced Therapies (CAT).

  • Update on the Guideline on the acceptability of names for human medicinal products processed through the centralised procedure – 15th December 2023

  • EMA Management Board: highlights of December 2023 meeting

  • Artificial intelligence workplan to guide use of AI in medicines regulation – 18th December 2023,benefit%20public%20and%20animal%20health.

  • Questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use – 5th January 2024


  • ICH Q14 Guideline on analytical procedure development - Step 5 Adopted
    Reference Number: EMA/CHMP/ICH/195040/2022. First published: 26th January 2024


  • MHRA New Notification Scheme – The new notification scheme enables a more streamlined and risk-proportionate approach to processing clinical trial authorisation (CTA) for “initial” applications.

  • UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care. - 25th January 2024


  • New general chapter on comparability of alternative analytical procedures published n Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.). – 18th December 2023,lifecycle%20of%20both%20analytical%20procedures.

Public Consultations

  • Reflection paper on the use of Artificial Intelligence (AI) in 6 the medicinal product lifecycle – Ended on 31st December 2023

  • Request for stakeholder feedback on the revised general chapter, Flow Cytometry (2.7.24) - Ended on 31st December 2023


Past events

  • Clinical Trials Information System (CTIS): Walk-in clinic – January 2024

  • Academia Info day – 10th November 2023

  • Webinar on new general chapter Comparability of alternative analytical procedures (5.27) – 17th January 2024

Upcoming Events