EU proposes new blood, tissues and cells Regulation
European Pharmaceutical Review
JULY 25, 2022
The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The Regulation will cover all SoHO (eg, blood, tissues, cells, breast milk and microbiota) except solid organs. A major aim of the proposal is to enhance the protection of recipients of SoHO therapies, as well as donors of SoHO and offspring from medically assisted reproduction.
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