26 May 2025
PPTA acknowledges the 22nd edition of the “Blood Guide,” published in May 2025 by the EDQM, which provides essential guidance on the preparation, use, and quality assurance of transfusible blood components. We commend EDQM’s efforts to advance standards and align practices to enhance donor and patient safety.
However, PPTA believes that greater clarity on source plasma donation for fractionation would be beneficial, especially where donor eligibility, testing and deferral criteria differ due to rigorous manufacturing protocols that ensure plasma-derived medicinal products (PDMP) safety and quality. PPTA encourages greater collaboration with the PDMP industry in future editions to ensure guidance continues to evolve alongside scientific advancements.
PPTA also welcomes the EDQM’s focus on increasing plasma collection in Europe to support PDMP supply through the introduction of two plasma collection approaches: the “standard approach” and the “individualised donor assessment” approach. The latter, which includes IgG monitoring and adverse event tracking, aligns well with evidence-based programs like those in Germany. While EDQM’s recommended seven-day donation interval marks an important step in balancing donor safety and collection targets, PPTA sees further opportunity to refine this approach by incorporating the growing body of evidence supporting shorter intervals with appropriate monitoring, as demonstrated in scientific studies and national practices across Europe.
PPTA is committed to supporting EDQM in this important work and contributing evidence-based insights to the development of future Blood Guide editions. We view this 22nd edition as a constructive advancement and look forward to continued collaboration to ensure guidance reflects the innovation and commitment shared across our industries to uphold donor health and PDMP safety.