IPOPI welcomes the Commission’s proposal for a Regulation on Substances of Human Origin
The International Patient Organisation for Primary Immunodeficiencies (IPOPI) welcomes the European Commission proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application published in July 2022.
IPOPI is pleased that this proposal effectively provides:
- recognition of the importance of patient safety and the need for high quality & safe medicines
- highlights the importance of ensuring the availability of SoHOs to ensure optimal patient access and sufficiency of supply
- a good step forward in recognises donor compensation as compatible with the standards concerning voluntary and unpaid nature of SoHO donations
IPOPI is looking forward to working with EU institutions to ensure that patients with PIDs are able to access safe and good quality plasma.