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EMA Clasification of ATMPs Reflection Paper

Tuesday the 1st July 2014

The European Medicines Agency (EMA) announced on 30 June 2025 the availability of a draft reflection paper entitled, “Classification of Advanced Therapy Medicines Products.” This paper is intended to provide guidance on the Advanced Therapy Medicinal Products (ATMPs) classification procedure, as well as the interpretation of key concepts of the definition of gene therapy medicinal products that include somatic cell therapy medicinal products, tissue engineered products, and combined advanced therapy medicinal products.

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The legislation and guidance that apply to the healthcare industries is forever changing. NSF Health Sciences will provide you with regular updates on what is new and will also provide you with expert interpretation of these changes - what they mean

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