To safeguard public health and ensure the quality and safety of blood screening and viral safety testing, high-risk in vitro diagnostic medical devices are required not only to undergo pre-market registration and evaluation, but also post-market surveillance and monitoring. To meet these regulatory and testing needs, the national laboratory of the Taiwan Food and Drug Administration (TFDA) has progressively established biological reference standards for diagnostic testing applications. Since 2004, TFDA has supplied seven types of antisera and nucleic acid reference standards for quality control of in vitro diagnostic medical devices, including standards for hepatitis B virus (HBV), hepatitis C virus (HCV), and parvovirus B19. These reference materials have supported the development of Taiwan’s biotechnology and diagnostic industries. In addition, related research achievements have been published in internationally recognized scientific journals, further enhancing the international visibility, credibility, and scientific standing of Taiwan’s national laboratory and biological reference standards.

Taiwan Food and Drug Administration, Ministry of Health and Welfare

The product complies with the principles outlined in WHO technical guidelines for the preparation of biological reference standards.

The TFDA’s biological reference standards are prepared and supplied in accordance with the principles established by the World Health Organization (WHO) for international biological reference materials. Quality control, preparation, and testing processes are implemented through international collaborative calibration studies and laboratory supervision systems to ensure product quality and consistency. Laboratory management is conducted in reference to ISO/IEC 17025 principles, and customer feedback mechanisms are incorporated to support continuous improvement and the development of new reference materials. In addition, all storage, transportation, and handling procedures for biological reference standards comply with regulations governing infectious biological materials to ensure biosafety and biosecurity. 2. Laboratory operations are managed in accordance with the principles of ISO/IEC 17025. Customer satisfaction surveys and feedback mechanisms are implemented to support continuous service improvement and the development of new reference materials. 3. Biological national reference standards are classified as infectious biological materials. Therefore, all procedures involving their handling, storage, transportation, and biosecurity are performed in compliance with the Regulations Governing the Management of Infectious Biological Materials to ensure product safety and biosafety compliance.

Following preparation, all biological national reference standards undergo quality inspection and collaborative calibration studies in accordance with WHO guidelines. Participating organizations include international reference laboratories and national institutions such as the U.S. FDA, the U.K. NIBSC, Germany’s PEI, Japan’s NIID, Australia’s NRL, Taiwan CDC, and other leading professional laboratories and diagnostic manufacturers. Test results are traceable to international primary reference standards and analyzed using statistical methods. Data outside the confidence interval are excluded to ensure the consistency, reliability, and quality of the reference standards through mutual collaboration and supervision among participating laboratories. 2. The stability testing is conducted according to ICH guidelines, including long-term and accelerated stability studies under various temperature and environmental conditions

To ensure the continued quality, stability, and suitability of biological reference standards after distribution, the TFDA continuously monitors product usage and collects feedback from users. Any abnormalities related to testing results, product performance, or operational procedures can be promptly reported and investigated by the Agency for root cause analysis and follow-up actions. In addition, periodic stability evaluations and quality assessments are conducted to continuously ensure the consistency and stability of the reference standards.

Yang YC, Shih DY, Tsai MH, Cheng CH, Cheng HF, Lo CF, Wang DY. A collaborative study to establish the first National Standard for HIV-1 RNA nucleic acid amplification techniques (NAT) in Taiwan. J Virol Methods. 2013 Aug;191(2):122-7.