Regulatory News

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HTA 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Clinical ProgrammeCAT publishes Monthly Report for July 2015CAT publishes Monthly Report for July 2015EMA publishes new draft guidance on fast track routes to marketing authorisationEMA publishes new draft guidance on fast track routes to marketing authorisationEMA announces workshop on facilitating the development of advanced therapies in September 2015EMA announces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 2015Early dialogue to support development of medicines for childrenEarly dialogue to support development of medicines for childrenFDA issue draft guidance on developing drugs for Duchenne Muscular DystrophyFDA issue draft guidance on developing drugs for Duchenne Muscular DystrophyFDA issues final guidance on early phase clinical trials for gene and cell therapiesFDA issues final guidance on early phase clinical trials for gene and cell therapiesEMA adopts Reflection Paper on Classification of ATMPsEMA adopts Reflection Paper on Classification of ATMPs