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
European Medicines Agency
Plasma Master File
- ePMF Database System (2015)
- Concept Paper on Revision of Guideline on Epidemiological Data on Blood Transmissible Infections (2014)
- Calculation Alert Levels for Assessing Collection Center Donor Quality for PMF Evaluation (2010)
- Corrective and Preventive Action Points to Consider to Address Centers Exceeding Alert Levels (2010)
- EMEA PMF Epidemiology Workshop with Industry Epidemiological Data Reporting Experience and Critical Analysis (2009)
- Submission of Epidemiological Data (2009)
- Overall Safety (2009)
- A Proposed Metric – Alert Levels – for Assessing PMF Holders' Source and Recovered Plasma Collection Centers for HIV, HCV and HBV (2009)
- PMF and Second Step Procedure in Italy (2006)
United States
Federal Affairs
State Affairs