Government & Industry Regulations
CSL Behring is committed to producing high-quality, safe and effective medicines and that each step of the plasma collection and manufacturing process meets or exceed the most stringent international standards for product safety in accordance with regulatory agencies worldwide.
CSL Behring biotherapies are manufactured in state-of-the-art facilities under stringent, controlled conditions. Each step of the manufacturing process contributes to the safety of the products. CSL Behring complies with all government regulations set forth by the countries in which we manufacture and market products. In the US, this includes the Clinical Laboratory Improvement Act (CLIA); and Occupational Safety and Health Act (OSHA). In Europe, we adhere to requirements established by the European Medicines Agency as well as requirements specified by each of the individual countries in which we operate.
In Germany, CSL Plasma centers are certified by the German Health Authority (GHA).
In the US, CSL Plasma participates in the National Donor Deferral Registry (NDDR), a nationwide database of plasma donors who have been permanently deferred from donating plasma. By excluding previously deferred plasma or blood donors, this system further ensures the safety of plasma and plasma products. Implementation of a European NDDR is being discussed by several European regulatory authorities.
CSL Behring complies with all government regulations set forth by the countries in which we operate, which include, but are not limited to:
• United States: US Food and Drug Administration, US Clinical Laboratory Improvement Act (CLIA) and Occupational Safety and Health Act (OSHA)
• Europe: European Medicines Agency
• Germany: German Health Authority, Paul Ehrlich Institute and regional authoritiess
• United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Japan: Ministry of Health, Labor and Welfare