Understanding The impact Of The EU's Updated SoHO Legislation On ATMPS

This article discusses the updated EU legislation on substances of human origin (SoHOs) and it's significant implications for advanced therapy medicinal products (ATMPs). This legislation aims to improve the quality and safety of SoHOs, promote cross-border exchange, and harmonize regulations across EU member states. It extends the scope of the legislation to include intestinal microbiota and breast milk and establishes a coordination board and competent authorities to oversee compliance. The new legislation also affects developers of ATMPs, as it now covers activities such as storage, distribution, import, and export. All parties involved in SoHO activities must comply with the regulation and appoint a responsible person to ensure adherence.