ADVOCACY
Resources
Explore resources and stay informed about EU policies affecting the plasma sector.
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SOHO REGULATION
The SoHO Regulation is a new EU legal framework aimed at enhancing the safety, quality, and accessibility of substances of human origin (SoHO) used for medical purposes. This regulation covers a wide range of critical SoHO, including plasma. It aims to improve harmonisation across Member States and strengthen the existing legal framework while being future proof, i.e. flexible to keep up with scientific and technical developments.
Specifically for plasma, which is essential for producing plasma-derived medicinal products (PDMPs), the regulation focuses on key areas such as on high safety and quality standards and up-to-date technical rules, donor safety and improve supply continuity of plasma.
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PHARMACEUTICAL REGULATION
The revision of the EU Pharmaceutical Legislation aims to enhance the security of the medicine supply, making them more available, accessible, and affordable across EU countries while also supporting the attractiveness of the EU pharmaceutical industry.
A revised framework has the potential to provide a robust set of provisions that will continue to ensure the safety and quality of human plasma used for manufacturing, while upholding the safety, quality, and efficacy of PDMPs.
INTERNATIONAL
PLASMA
AWARENESS WEEK
International Plasma Awareness Week (IPAW) is held annually during the first week of October to raise global awareness about source plasma collection, recognise the valued contributions of donors, and increase understanding about plasma-derived medicines and rare diseases.
