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!