IPFA Position on EU SoHO Regulation Proposal

20 September 2022

The European Commission’s invitation to IPFA to comment on its proposal for a new Regulation on Substances of Human Origin (SoHOs) reflects many of IPFA recommendations. IPFA is particularly appreciative that plasma for fractionation is now included within the definitions and obligations of SoHOs, resulting in its recognition as part of the human body and superseding its status as a commodity.

In addition, measures to protect donors and preserve the concept of voluntary unpaid donation are now embedded in this regulation. IPFA notes that the EC requires that competent authorities which act in the public interest are appropriately resourced and equipped and appreciates the implication by the EC that member states should encourage public sector involvement in the collection of plasma for fractionation.

Read IPFA’s full comments: IPFA Position Papers – IPFA


Dr. Françoise Rossi
Director of Scientific and Regulatory Affairs