Hind Al Belushi, PhDISCT Legal and Regulatory Affairs Committee: EuropeRoyal HospitalSultanate of Oman
Committee of Advance Therapy (CAT)
Minutes of the meetings
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-6-8-october-2021_en.pdfhttps://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-8-10-september-2021_en.pdf https://www.ema.europa.eu/en/documents/minutes/minutes-cat-written-procedure-11-13-august-2021_en.pdf
Agendas
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-19-21-january-2021-meeting_en.pdf https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-8-10-december-2021-meeting_en.pdf
Monthly report
https://www.ema.europa.eu/en/documents/report/cat-monthly-report-application-procedures-guidelines-related-documents-advanced-therapies-december_en.pdf
Updates and regulatory news
A faster path to UK trials approvals: Combined review for clinical trials of investigational medicinal products (CIMPS) service launches.
https://www.medcityhq.com/2022/01/27/a-faster-path-to-uk-trials-approvals-ctimp-review-service-launches/
Regulatory harmonization of clinical trials in the EU: Clinical Trials Regulation (CTR) to enter application and new Clinical Trials Information System (CTIS) to be launched.
https://www.ema.europa.eu/en/news/regulatory-harmonisation-clinical-trials-eu-clinical-trials-regulation-enter-application-new
Revision1 of ICH Q9 Quality Risk Management (ICH harmonized guideline)
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals_en-1.pdf
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its January 2022 meeting. The CHMP gave a positive opinion for the new gene therapy Breyanzi* (lisocabtagene maraleucel) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two previous lines of treatment.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-january-2022
Open consultations
Consultation on proposals for legislative changes for clinical trials to improve and strengthen UK clinical trials legislation from Medicine and Healthcare products regulatory agency.
https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials.
Open to 14th March 2022.
Call to join a CT/CI assessment pilot of a new processes within the combined review application service for clinical trials of investigational medicinal products (CIMPS) aimed to improve the efficiency and speed of the applications.
https://medregs.blog.gov.uk/2022/01/27/lead-the-way-towards-a-combined-ct-ci-assessment-by-joining-our-pilot/
Open now
Call for comments for a concept paper on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy.
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-data-requirements-potency-tests-cell-based-therapy-products-relation_en.pdf
Open to 29th April 2022
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