Regulatory News

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BIA publishes briefing paper on ATMPs and regenerative medicineBIA 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 studiesEMA releases new guidance on methods to be used in the design and conduct of post-authorisation efficacy studiesUS Guidance for Industry updateUS Guidance for Industry updateEMA implements new system for better reporting of suspected adverse reactions to medicines via EudraVigilanceEMA 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 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 issues positive opinion to Amgen’s advanced therapy, Imlygic™ (T-Vec)EMA launches new patient registry initiative for collection of clinical dataEMA launches new patient registry initiative for collection of clinical dataCAT publishes Monthly Report for September 2015CAT publishes Monthly Report for September 2015US 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 ATMPs