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EMA Guidance on Advanced Therapy Medicinal Products (ATMPs)

Jan 31, 2022

EMA Guidance on Advanced Therapy Medicinal Products (ATMPs)

The European Medicines Agency (EMA) has recently published a quick and useful guidance on different aspects related to the Advanced Therapy Medicinal Products (ATMPs):

  • Non-clinical development. The guide aims to help developers of gene therapy medicinal products (GTMPs) and cell-based medicinal products (CBMPs) navigate the most important regulatory requirements during the non-clinical development phase. Guide - checklist
  • Clinical development. The guide aims to help developers of GTMPs and CBMPs navigate the most important regulatory requirements during the clinical development phase. Guide - checklist
  • Quality. The guide aims to help developers of GTMPs and CBMPs navigate the most important quality-related regulatory requirements. Guide - checklist

Stay tuned for further updates!

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