Changes and Prospects of Infectious Biological Materials Management in Taiwan

Wen-Chao Wu, Wei-Shi Tsai, Shu-Hui Tseng

2014 Vol.30 NO.21

Correspondence Author: Wen-Chao Wu

  • Division of Infection Control and Biosafety, Centers for Disease Control, Ministry of Health and Welfare, Taiwan


       The "Regulations Governing Management of Infectious Biological Materials" was announced on March 11, 2014. It makes laboratory biosafety regulations more appropriate and complete. In addition to deleting the relevant regulations on infectious patient specimen collection from the previous "Regulations Governing Management of Infectious Biological Materials and Collection of Specimens from Patients of Communicable Diseases", the major amendments include: (1) defining organizational entity which relates to infectious biological materials; (2) the management of infectious biological materials focuses on the risk group 2 and above microorganisms and biological toxins; (3) clarifying the qualifications of the biosafety committee and the biosafety staff; (4) amending the safety equipment requirements of biosafety level 2 laboratory; (5) the establishment of reporting mechanism of the risk group 2 and above microorganisms and biological toxins; (6) setting triple packaging rules regarding infectious biological material transport packaging requirements; (7) offering the safety management responsibilities to local health authorities; (8) amending the medical monitoring and education/training requirements of laboratory personnel. To ensure that laboratory biosafety management in Taiwan fit into international trends, the "Laboratory Biorisk Management Strategic Framework for Action 2012-2016" released by World Health Organization in 2012 is followed, and shall gradually promote the policy of laboratory biorisk management system, set capability of the installation units to implement self-management and biosafety committee, ensure safety works of the laboratory staff in Taiwan.

Keywords:infectious biological materials, laboratory biosafety, risk group, biosafety committee, biorisk management