Alejandro Barquero, MPharm, MScISCT Legal and Regulatory Affairs Committee: EuropeDanausGT Biotech Ltd.Spain
Laura Mendieta, PhDISCT Legal and Regulatory Affairs Committee: EuropeAsphalionSpain
Committee of Advance Therapy (CAT)
Committee for Advanced Therapies (CAT): Work Plan 2023https://www.ema.europa.eu/en/documents/other/committee-advanced-therapies-cat-work-plan-2023_en.pdf
Minutes of the meetings
Minutes of the meeting on 7-9 December 2022 https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-7-9-december-2022_en.pdf
Agendas
Draft Agenda for the meeting on 15-17 February 2023https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-15-17-february-2023_en.pdf
CAT meetings in 2025 and 2026https://www.ema.europa.eu/en/documents/other/cat-meetings-2025-2026_en.pdf
Updates and regulatory news
European Parliament votes to extend Medical Device Regulation (MDR) transition period to avoid a shortage of life-saving products in the economic region and to extend the validity of certain device certificates.https://www.europarl.europa.eu/doceo/document/TA-9-2023-0052_EN.pdf
EMA Regulatory and scientific virtual conference on RNA-based medicines https://www.ema.europa.eu/en/events/regulatory-scientific-virtual-conference-rna-based-medicines#video-recording-section
EMA virtual technical media briefing on the RNA technology.https://www.ema.europa.eu/en/events/ema-virtual-technical-media-briefing-rna-technology
The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 01 January 2023. The Ph. Eur. 11th Edition and its supplements are available to subscribers on the dedicated European Pharmacopoeia online platform.https://pheur.edqm.eu/home
ICH Q9 (R1) guideline has reached stage 4 of the process as of 18 January 2023 and will become effective as of 23 July 2023.https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-17.pdf
UK NICE - More than 400 people set to benefit after NICE approves ground-breaking CAR-T therapy to treat aggressive form of blood cancer – February 26th https://www.nice.org.uk/guidance/ta872/documents/final-appraisal-determination-document
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 yearshttps://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years
Guidance Documents
The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023.https://database.ich.org/sites/default/files/ICH_S12_Step4_Guideline_2023_0314.pdf
Accelerating Clinical Trials in the European Union (ACT EU) - Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trialshttps://www.ema.europa.eu/en/documents/scientific-guideline/priority-action-3-concept-paper-eu-multi-stakeholder-platform-improving-clinical-trials-accelerating_en.pdf
Recommendation paper on decentralised elements in clinical trials https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf
Quick guide for sponsors – Clinical Trials Regulation 536/2014 in practice (Eudralex vol. 10)https://health.ec.europa.eu/system/files/2023-01/mp_ctr-536-2014_guide_en.pdf
Open consultations
The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1https://www.edqm.eu/en/-/public-consultation-on-ph.-eur.-rabbit-pyrogen-test-replacement-texts-in-pharmeuropa-35.1 Open to 31 March 2023
EMA Reflection paper on the “Criteria to be considered for the evaluation of new active substance (NAS) status of biological substances” open consultationhttps://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-criteria-be-considered-evaluation-new-active-substance-nas-status-biological_en.pdfOpen to 31 March 2023
British Pharmacopoeia - Non-mandatory, best practice guidance for T cell and NK cell characterisation assayshttps://www.pharmacopoeia.com/bp-consultations/guidance-on-t-cell-and-nk-cell-characterisation-assays Open to 01 May 2023
Concluded consultations
ICH guideline Q5A (R2) Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Step 3 closed for comments. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-r2-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-animal-origin_en.pdfConsultation closed on 10 February 2023
ICH guideline M11, Cclinical electronic structured harmonised protocol (CeSHarP). Step 3 closed for comments. https://database.ich.org/sites/default/files/ICH_M11_draft_Guideline_Step2_2022_0904.pdfConsultation closed on 26 February 2023
EMA guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-data-requirements-potency-tests-cell-based-therapy-products-relation_en.pdfConsultation closed on 28 February 2023
Public consultation on a multi-stakeholder platform to improve clinical trials in the EUhttps://www.ema.europa.eu/en/news/public-consultation-multi-stakeholder-platform-improve-clinical-trials-eu Consultation closed on 03 March 2023