News Hub

EU LRA Watchdog - October 2023



Alejandro Barquero, MPharm, MSc
DanausGT Biotech Ltd.


Committee of Advance Therapy (CAT)

Minutes of the meetings

Minutes of the meeting on 15-17 May 2023

Minutes of the meeting on 15 June 2023

Minutes of the meeting on 12-14 July 2023

Minutes of the meeting on 09-11 August 2023



Agenda for the meeting on 06-08 September 2023



CAT quarterly highlights and approved ATMPs, published May-July (first published 24-Jul-2023)


Updates and regulatory news

EMA - Strengthening life-sciences innovation across Europe: EU-Innovation Network conference

The European Innovation Network (EU-IN) is organising a conference hosted by the Health Products Regulatory Authority (HPRA) with European incubators and technology transfer offices (TTOs) to power and support the translation of innovative biopharmaceutical and medical technology developments.


EMA - Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS (15-Sep)

EMA - Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies (15-Sep)

MHRA – Guidance International Recognition Procedure published (30-Aug)

From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP

MHRA performance data for assessment of clinical trials and established medicines (15-Sep)

UK patients set to have faster access to innovative medical technologies via new pathway (19-Sep)

EDQM - Ph. Eur. allows the use of recombinant factor C for control of bacterial endotoxins in water monographs (19-Sep)

European Pharmacopoeia Workshop in New Jersey (USA), 24-25 October 2023,Eur


Guidance Documents

  • No updated guidelines have been published in the EU region since previous Watchdog report.


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

Also, a joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop is organised in November, 2023. Registrations will open in September.


Concluded consultations

­Reflection paper on establishing efficacy based on single arm trials submitted as pivotal evidence in a marketing authorisation under consultation.

Closed on: 30 September 2023

Draft version of ICH E6(R3) Harmonised Guideline Good Clinical Practice has been endorsed on 19 May 2023 and it is currently under public consultation.

Closed on: 26 September 2023

International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines

Closed on: 30 September 2023

MHRA - Consultation on end to the European Commission Decision Reliance Procedure

Closed on: 30 August 2023