Regulatory Policy

RegulatoryTopBar1PPTA 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.

Regulatory and quality policies affect every step of the plasma protein therapy lifecycle, which includes:

    • Donor Safety—ensuring that donors are healthy enough to donate and monitoring the safety of donors during and after the donation process
    • Quality and Compliance—licensing and inspecting of plasma collection centers and plasma protein therapy manufacturing facilities
    • Biological License Application Process—obtaining regulatory approval of a therapy for the treatment of specific condition(s) known as indication(s)
    • Therapy Safety and Efficacy—requiring clinical studies showing safety and efficacy prior to regulatory approval
    • Pharmacovigilance—after regulatory approval, engaging in "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems" (WHO)

European Union

Comments to the European Commission
European Medicines Agency

United States

Source Plasma (Comments/Letters to/from the U.S. Food and Drug Administration [FDA])
Final Therapies (Comments to FDA)

PPTA Letter to HHS Secretary Azar (2020)

State Affairs


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