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Expert Analysis

A Primer On EU's Updated Human Substance Regulations

By Geneviève Michaux and Georgios Symeonidis (August 6, 2024, 6:54 PM EDT) -- On July 17, the European Union adopted a regulation on standards of quality and safety for substances of human origin, or SoHOs, intended for human application. The SoHO regulation, which updates and replaces the EU Blood Directive[1] and the EU Tissue and Cells Directive[2] — collectively, the blood, tissues and cells legislation, or BTC legislation — will become applicable by mid-2027....

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