News Hub

EU LRA Watchdog - December 2023



Laura Mendieta, PhD
ISCT Legal and Regulatory Affairs Committee: Europe

Alejandro Barquero, MPharm, MSc
ISCT Legal and Regulatory Affairs Committee: Europe
DanausGT Biotech Ltd.


Committee of Advance Therapy (CAT)

Minutes of the meetings

Minutes for the meeting on 6-8 September


Minutes for the meeting on 4-6 October



Agenda for the meeting on 30-31 October


Upcoming meeting: 6, 7, 8 December 2023



CAT quarterly highlights and approved ATMPs – 11th October 2023




Update on “European Medicines Agency Guidance for applicants seeking access to PRIME scheme” – 29th September 2023

Revised CTIS Transparency Rules – 5th October 2023

Update on “Quick guide: Clinical Study Reports submission - CTIS Training Programme - Module 13” – 7th November 2023

CTIS newsflash – 10th November 2023

Update on the Clinical Trials Information System (CTIS) - Sponsor Handbook – 6th November 2023

Update on the Guide to information on human medicines evaluated by EMA (EMA/384375/2023) – 13th November 2023

Updated template for scientific document (B-F) for PIP submissions – 13th November 2023

The CTCG Best Practice Guide on transition trials has been updated to Version 3 (adopted at the CTCG plenary November 13, 2023) and published on 28 November 2023. This update includes clarifications on consolidated protocols, background treatment and Consolidation of Investigator’s brochures (IB) and/or Investigational Medicinal Product Dossier (IMPD) not previously harmonized under CTD.

The Transition application cover letter template has also been updated:


Questions & Answers: Clinical Trials Regulation (EU) No 536/2014 – 29th September

Blood, tissues and cells: EU to guarantee high standards of quality and safety. EMA press release on October 25th.

The Council agreed its negotiating mandate on the proposed regulation on blood, tissues and cells. The new regulation ensures better protection of donors, recipients and children born following medically assisted reproduction. The proposed new rules aim to strengthen the existing legal framework and to add additional flexibility in order to keep up with scientific and technical developments.



MHRA Business Plan 2023-2024 – 1st September 2023

MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia – 16th November 2023



OMCL Gene Therapy Working Group Study published - Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations



The 12th meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 1st and 2nd of November 2023 Prague, Czech Republic. 29 IPRP Members and Observers were represented at the meeting. The MC welcomed two new IPRP MC Members: The Algerian Regulatory Authority – ANPP, Algeria; and the Jordanian Regulatory Authority – JFDA, Jordan.


Open consultations

EMA is seeking input on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.

Open from 19 July 2023 to 31 December 2023

Request for stakeholder feedback on the revised general chapter, Flow Cytometry (2.7.24)

Open up to 31 December 2023


Concluded consultations

ICCBBA seeks comments on IG-050. The International Council for Commonality in Blood Banking Automation (ICCBBA) was seeking public comments on the draft version of the Implementation Guide Using the ISBT 128 Chain of Identity (CoI) Identifier (IG-050).

Closed on November 20th



Past events

MHRA Board Meeting – September 2023


SoGATs (Standardisation of Genome Amplification Techniques and serology) Workshop 2023- 4th to 6th October 2023


Annual workshop of the European network of paediatric research at EMA (Enpr-EMA) - 10th October 2023


Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop – Smart regulation in a rapidly evolving world - 20th -21st of November 2023


Strengthening life-sciences innovation across Europe: EU-Innovation Network conference – 21st November 2023


Awareness session for SMEs on the reform of the EU pharmaceutical legislation – 24th November 2023


Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS pre-requisites, and updates on transparency rules – 29th November 2023


Second European Medicines Agency (EMA) and EUCOPE bilateral meeting – 29th November 2023

Upcoming events

EMA website relaunch – 5th December


Clinical Trials Information System (CTIS) sponsor end user training programme – 11th to 14th December 2023

Clinical Trials Information System (CTIS): Walk-in clinic – 13th December 2023