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Regulatory affairsRegulatory Round-up - January 2026
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US Guidance for Industry and FDA publications updateUS Guidance for Industry and FDA publications updateFDA issues Guidance for Industry on submissions for HLA testing kitsFDA issues Guidance for Industry on submissions for HLA testing kitsFDA issues final guidance on the design and analysis of shedding studiesFDA issues final guidance on the design and analysis of shedding studiesHTA provides statement on regulation of blood as a starting material for ATMPsHTA provides statement on regulation of blood as a starting material for ATMPsHTA announces workshops on updated codes of practiceHTA announces workshops on updated codes of practiceEMA releases addendum to ICH E6 guideline on good clinical practiceEMA releases addendum to ICH E6 guideline on good clinical practiceUK Cell Therapy GMP Manufacturing Capacity and Capability IncreasesUK Cell Therapy GMP Manufacturing Capacity and Capability IncreasesCollaboration to Improve Viral Vector Industrialisation ProcessCollaboration to Improve Viral Vector Industrialisation ProcessCell Therapy Catapult Awards Major Contract to Cellular Therapeutics Limited to Accelerate WT1 Clinical ProgrammeCell Therapy Catapult Awards Major Contract to Cellular Therapeutics Limited to Accelerate WT1 Clinical ProgrammeCAT publishes Monthly Report for July 2015CAT publishes Monthly Report for July 2015EMA publishes new draft guidance on fast track routes to marketing authorisationEMA publishes new draft guidance on fast track routes to marketing authorisationEMA announces workshop on facilitating the development of advanced therapies in September 2015EMA announces workshop on facilitating the development of advanced therapies in September 2015