Mapping the European Regulatory Overlap in ATMP Guidance

Published on Cytotherapy

A recent publication in Cytotherapy reviewed 88 European guidance documents related to advanced therapy medicinal products (ATMPs). The study highlights the complexity and overlap of regulatory guidance that applies not only to ATMPs, but also to biosimilars, blood products, and other biologics. Many of these documents are hard to navigate, with unclear applicability and limited disease-specific context. The authors propose better structure, categorisation, and harmonisation to make guidance more user-friendly, especially for emerging developers in cell and gene therapy.

Read the full article on Cytotherapy:

👉 Mapping the European Landscape and Specificity of ATMPs Guidance

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