by
Laura Mendieta, PhD
ISCT Legal and Regulatory Affairs Committee: Europe
Asphalion
Spain
Alejandro Barquero, MPharm, MSc
ISCT Legal and Regulatory Affairs Committee: Europe
DanausGT Biotech Ltd.
Spain
.
Committee of Advance Therapy (CAT)
Minutes of the meetings
Minutes for the meeting on 6-8 September
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-06-08-september-2023_en.pdf
Minutes for the meeting on 4-6 October
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-4-6-october-2023_en.pdf
.
Agenda
Agenda for the meeting on 30-31 October
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-30-31-october-2023_.pdf
Upcoming meeting: 6, 7, 8 December 2023
https://www.ema.europa.eu/en/events/committee-advanced-therapies-cat-6-8-december-2023
Other
CAT quarterly highlights and approved ATMPs – 11th October 2023
https://www.ema.europa.eu/en/documents/report/cat-quarterly-highlights-approved-atmps-october-2023_en.pdf
.
UPDATES AND REGULATORY NEWS
EMA
Update on “European Medicines Agency Guidance for applicants seeking access to PRIME scheme” – 29th September 2023
https://www.ema.europa.eu/en/documents/other/european-medicines-agency-guidance-applicants-seeking-access-prime-scheme_en-0.pdf
Revised CTIS Transparency Rules – 5th October 2023
https://www.ema.europa.eu/en/documents/other/revised-ctis-transparency-rules_en.pdf
Update on “Quick guide: Clinical Study Reports submission - CTIS Training Programme - Module 13” – 7th November 2023 https://www.ema.europa.eu/en/documents/other/quick-guide-clinical-study-reports-submission-ctis-training-programme-module-13_en.pdf
CTIS newsflash – 10th November 2023
https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-10-november-2023_.pdf
Update on the Clinical Trials Information System (CTIS) - Sponsor Handbook – 6th November 2023
https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_.pdf
Update on the Guide to information on human medicines evaluated by EMA (EMA/384375/2023) – 13th November 2023
https://www.ema.europa.eu/en/documents/other/guide-information-human-medicines-evaluated-european-medicines-agency-what-agency-publishes-when_.pdf
Updated template for scientific document (B-F) for PIP submissions – 13th November 2023
https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans/paediatric-investigation-plans-templates-forms-submission-dates
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.
https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2023_11_CTCG_Best_Practice_Guide_for_sponsors.pdf
The Transition application cover letter template has also been updated:
https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2023_11_CTCG_Annex_cover_letter_template_-_CTCG_Best_Practice_Guide_for_sponsors_on_transition_vs3.docx
Questions & Answers: Clinical Trials Regulation (EU) No 536/2014 – 29th September
https://health.ec.europa.eu/system/files/2023-09/regulation5362014_qa_en.pdf
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.
https://www.consilium.europa.eu/en/press/press-releases/2023/10/25/blood-tissues-and-cells-eu-to-guarantee-high-standards-of-quality-and-safety/
MHRA
MHRA Business Plan 2023-2024 – 1st September 2023
https://assets.publishing.service.gov.uk/media/65008bd91886eb000d977228/Business_plan-Sept-12-2023.pdf
MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia – 16th November 2023
https://www.gov.uk/government/news/mhra-authorises-world-first-gene-therapy-that-aims-to-cure-sickle-cell-disease-and-transfusion-dependent-thalassemia
EDQM
OMCL Gene Therapy Working Group Study published - Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations
https://pbiosn.edqm.eu/app/pbiosn/content/pbiosn/2023-3_qPCR_method_for_determination_of_viral_genome_titres_of_AAV2-based_vector_preparations.pdf
IPRP
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.
https://admin.iprp.global/sites/default/files/2023-11/IPRP12_PublicStatement_Final_2023_1120.pdf
.
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
Request for stakeholder feedback on the revised general chapter, Flow Cytometry (2.7.24)
https://www.edqm.eu/en/-/pharmeuropa-35.4-just-released
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).
https://2965e4ff-bb0f-4761-93dd-2a4f4b0f59e2.usrfiles.com/ugd/2965e4_c91d8c3bedfb42c693bb59606e78a680.pdf
Closed on November 20th
..
.
Past events
MHRA Board Meeting – September 2023
https://www.youtube.com/watch?v=eq2kOXOBh6c
SoGATs (Standardisation of Genome Amplification Techniques and serology) Workshop 2023- 4th to 6th October 2023
https://mhrasogats.co.uk/home
Annual workshop of the European network of paediatric research at EMA (Enpr-EMA) - 10th October 2023
https://www.ema.europa.eu/en/events/annual-workshop-european-network-paediatric-research-ema-enpr-ema
Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop – Smart regulation in a rapidly evolving world - 20th -21st of November 2023
https://www.ema.europa.eu/en/events/joint-heads-medicines-agencies-hma-european-medicines-agency-ema-ai-workshop-smart-regulation
Strengthening life-sciences innovation across Europe: EU-Innovation Network conference – 21st November 2023
https://www.ema.europa.eu/en/events/strengthening-life-sciences-innovation-across-europe-eu-innovation-network-conference#event-summary-section
Awareness session for SMEs on the reform of the EU pharmaceutical legislation – 24th November 2023
https://www.ema.europa.eu/en/events/awareness-session-smes-reform-eu-pharmaceutical-legislation
Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS pre-requisites, and updates on transparency rules – 29th November 2023
https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-bitesize-talk-training-materials-ctis-pre-requisites-updates
Second European Medicines Agency (EMA) and EUCOPE bilateral meeting – 29th November 2023
https://www.ema.europa.eu/en/events/second-european-medicines-agency-ema-and-eucope-bilateral-meeting
Upcoming events
EMA website relaunch – 5th December
https://www.ema.europa.eu/en/news/getting-ready-emas-website-relaunch-5-december-2023
Clinical Trials Information System (CTIS) sponsor end user training programme – 11th to 14th December 2023
https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-sponsor-end-user-training-programme-december-2023
Clinical Trials Information System (CTIS): Walk-in clinic – 13th December 2023
https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-walk-clinic-december-2023
#RegulatoryWatchdog