EU LRA Watchdog - February 2024

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

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

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Committee of Advance Therapy (CAT)

Minutes of the meetings

Minutes for the meeting on 6-8 December 2023

https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-6-8-december-2023_en.pdf

Agendas for upcoming meetings

Agenda for the meeting on 14-16 January 2024

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-17-19-january-2024_en.pdf

Updates from Regulatory Agencies

Updates from the EMA

CTIS newsflash – 24th November 2023

https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-24-november-2023_en.pdf

Relaunched EMA website – 5th December 2023

https://www.ema.europa.eu/en/news/relaunched-ema-website-now-live

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

https://www.ema.europa.eu/en/documents/presentation/presentation-eu-eu-health-policy-pharmaceutical-reform-lilia-luchianov-dg-sante-ec_en.pdf

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

https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf

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.

https://www.ema.europa.eu/en/news/global-regulators-strengthen-efforts-ensure-continuous-availability-safe-and-high-quality-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 transfusion‑dependent β‑thalassemia (TDT) and sickle cell disease (SCD) following the assessment by the Committee for Advanced Therapies (CAT).

https://www.ema.europa.eu/en/medicines/human/EPAR/casgevy

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

https://www.ema.europa.eu/en/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure-scientific-guideline

EMA Management Board: highlights of December 2023 meeting

https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2023-meeting

Artificial intelligence workplan to guide use of AI in medicines regulation – 18th December 2023

https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation#:~:text=The%20workplan%20will%20help%20the,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

https://www.ema.europa.eu/en/documents/other/questions-and-answers-stakeholders-implications-regulation-eu-2023-1182-centrally-authorised-medicinal-products-human-use_en.pdf

ICH

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

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q14-guideline-analytical-procedure-development-step-5_en.pdf

MHRA

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.

https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#new-notification-scheme

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

https://www.gov.uk/government/news/uk-to-introduce-first-of-its-kind-framework-to-make-it-easier-to-manufacture-innovative-medicines-at-the-point-of-care#:~:text=The%20UK%20will%20be%20the

EDQM

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

https://www.edqm.eu/en/-/new-general-chapter-on-comparability-of-alternative-analytical-procedures-published-in-european-pharmacopoeia#:~:text=The%20text%20provides%20practical%20guidance,lifecycle%20of%20both%20analytical%20procedures.

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