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Regulatory NewsRegulatory Round-up - March 2025
Cell Therapy Catapult signs Memorandum of Understanding with Kanagawa Prefecture, JapanBIA publishes briefing paper on ATMPs and regenerative medicineEMA releases new guidance on methods to be used in the design and conduct of post-authorisation efficacy studiesConstruction initiated on Cell Therapy Catapult’s £55 million cell and gene therapy manufacturing centreUS Guidance for Industry updateEMA implements new system for better reporting of suspected adverse reactions to medicines via EudraVigilanceEMA continues its efforts to facilitate early patient access to innovative medicines through initiation of PRIME schemeEMA issues positive opinion to Amgen’s advanced therapy, Imlygic™ (T-Vec)EMA launches new patient registry initiative for collection of clinical dataCAT publishes Monthly Report for September 2015US Guidance for Industry and FDA publications updateFDA issues Guidance for Industry on submissions for HLA testing kits
