Resources

PPTA welcomes the revision of the EU pharmaceutical legislation as an opportunity to improve access to therapies, including life-saving plasma-derived medicinal products (PDMPs) for EU patients. 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.

The CBER Surveillance Program BEST Initiative recently posted its Assessment of Immune Globulin Utilization in Commercially insured and Medicare Populations study report. The aim of the study is to provide a better picture of the evolution of Ig use over a 10-year longitudinal period in the context of emerging scientific evidence and clinical trends. PPTA developed an Executive Summary of the study report, highlighting key observations, findings, and conclusions.

PPTA advocates for rational regulatory policy through active dialogue with regulatory authorities throughout the world. PPTA supports regulatory policies that help ensure the safety and quality of plasma protein therapies. Regulatory staff respond to policy documents and issues, as needed, and are actively engaged on issues ranging from the collection of source plasma through the manufacture of therapies that are administered to patients. As regulations may differ in various parts of the world, PPTA also works to promote harmonization among them, where beneficial.

PPTA and its member companies adhere rigorously to international regulatory requirements and industry voluntary standards through PPTA's IQPP and QSEAL programs to ensure that patients have access to safe state-of-the-art therapies for the treatment of often life-threatening diseases.