In 2001, the Executive Yuan approved the National Blood for National Health Policy to promote the use of blood from blood donation and blood preparation by commissioned manufacturers. The goal is to be self-sufficient and provide the nationals with safe blood preparation for medical use in order to ensure the health of the nationals. According to the National Blood for National Health Policy, the “national blood” is defined as the blood from blood donation by the nationals and the blood preparation thereof. To improve safety and quality of blood preparation and ensure its stable supply, the Plasma Derivatives Act was formulated to authorize the central competent authority to develop the Blood Preparation Development Program to promote relevant development measures to ensure stable supply of blood preparation in the country.
To be in line with the national policy, TBSF screened plasma raw materials that were voluntarily donated from eligible nationals. After the raw materials passed virus mark test and highly sensitive nucleic acid amplification testing (NAT), they were entrusted to the Australian-based PIC/S GMP CSL Behring plasma factory, which has been approved by the Food and Drug Administration, Ministry of Health and Welfare for manufacturing four products: ““TBSF” (20%) Human Albumin Solution, “TBSF” Human Immunoglobulin for Intravenous Use, “TBSF” High Purity Factor VIII / Von Willebrand Factor Concentrate, and“TBSF” High Purity Factor IX Concentrate.
From national plasma raw materials to final “TBSF” blood products, the whole process is checked by the Therapeutic Goods Administration (TGA) in Australia and the Food and Drug Administration, Ministry of Health and Welfare (TFDA) to ensure the quality and safety, from plasma raw materials screening to final blood preparation, is in line with international standards so that the rights and interests of domestic patients are ensured.