Hind Al Belushi, PhDISCT Legal and Regulatory Affairs Committee: EuropeRoyal HospitalSultanate of Oman
Committee for Advanced Therapies (CAT)
The Committee for Advanced Therapies (CAT) is the European Medicines Agency's (EMA) committee responsible for assessing the quality, safety, and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.
Recently added meeting documents
Minutes of the meetings
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-8-10-december-2021_en.pdf
Agendas
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-11-13-april-2022-meeting_en.pdf
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-18-march-2022-meeting_en.pdf
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-17-february-2022-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 new gene therapy, Carvykti* (ciltacabtagene autoleucel), received a positive opinion for a conditional marketing authorisation for the treatment of multiple myeloma. Carvykti had support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. Janssen.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-march-2022
Open consultations
Forms for comments for EMA open consultations
https://www.ema.europa.eu/en/news-events/open-consultations
ICH guideline Q2(R2) on validation of analytical procedures Step 2b
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf
Open to 31/07/2022
ICH guideline Q14 on analytical procedure development Step 2b
https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q14-analytical-procedure-development-step-2b_en.pdf
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