by
Alejandro Barquero, MPharm, MScDanausGT Biotech Ltd.Spain
.
Committee of Advance Therapy (CAT)
Minutes of the meetings
Minutes of the meeting on 15-17 May 2023
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-15-17-may-2023_en.pdf
Minutes of the meeting on 15 June 2023
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-15-june-2023_.pdf
Minutes of the meeting on 12-14 July 2023
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-12-14-july-2023_en.pdf
Minutes of the meeting on 09-11 August 2023
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-9-11-august-2023_en.pdf
Agenda
Agenda for the meeting on 06-08 September 2023
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-6-8-september-2023_en.pdf
Other
CAT quarterly highlights and approved ATMPs, published May-July (first published 24-Jul-2023)
https://www.ema.europa.eu/en/documents/report/cat-quarterly-highlights-approved-atmps-july-2023_en.pdf
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.
https://www.ema.europa.eu/en/events/strengthening-life-sciences-innovation-across-europe-eu-innovation-network-conference
Registration: https://ec.europa.eu/eusurvey/runner/EU-INWorkshopRegistration2023
EMA - Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS (15-Sep)
https://www.ema.europa.eu/en/events/webinar-regulatory-procedure-management-product-lifecycle-management-1st-roll-out-iris
EMA - Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies (15-Sep)
https://www.ema.europa.eu/en/news/towards-permanent-collaboration-framework-ema-health-technology-assessment-bodies
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
https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure
MHRA performance data for assessment of clinical trials and established medicines (15-Sep)
https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines
UK patients set to have faster access to innovative medical technologies via new pathway (19-Sep)
https://www.gov.uk/government/news/uk-patients-set-to-have-faster-access-to-innovative-medical-technologies-via-new-pathway
EDQM - Ph. Eur. allows the use of recombinant factor C for control of bacterial endotoxins in water monographs (19-Sep)
https://www.edqm.eu/en/-/ph.-eur.-allows-the-use-of-recombinant-factor-c-for-control-of-bacterial-endotoxins-in-water-monographs
European Pharmacopoeia Workshop in New Jersey (USA), 24-25 October 2023
https://www.edqm.eu/en/-/european-pharmacopoeia-workshop-in-new-jersey-usa-24-25-october-2023-new-exclusive-workshop-format-reduced-prices-#:~:text=Join%20us%20in%20Iselin%2C%20New,Eur
Guidance Documents
Open consultations
EMA is seeking input on the use of Artificial Intelligence (AI) in the medicinal product lifecycle.
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf
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.
https://www.ema.europa.eu/en/events/joint-heads-medicines-agencies-hma-european-medicines-agency-ema-ai-workshop-smart-regulation
Concluded consultations
Reflection paper on establishing efficacy based on single arm trials submitted as pivotal evidence in a marketing authorisation under consultation.
https://www.ema.europa.eu/en/establishing-efficacy-based-single-arm-trials-submitted-pivotal-evidence-marketing-authorisation
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.
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf
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
https://admin.ich.org/sites/default/files/2023-06/ICH_ReflectionPaper_Harmonisation_RWE_Terminology_Endorsed-ForConsultation_2023_0613.pdf
MHRA - Consultation on end to the European Commission Decision Reliance Procedure
https://www.gov.uk/government/consultations/consultation-on-end-to-the-european-commission-decision-reliance-procedure
Closed on: 30 August 2023