Major Change in Taiwan’s “Regulations of Inspection and Sealing for Biological Drugs”


The Department of Health, Executive Yuan promulgated part of the amended articles of Taiwan’s “Regulations of Inspection and Sealing for Biological Drugs” (including Appendices) (Ordain Shu-Shou-Shih-Zih-Di No. 1011403207) on June 1, 2012. The original regulations have been in effect since May 17, 2004 and had never been amended ever since. This amendment is made corresponding to temporal and spatial changes, organizational reform, as well as the standardized operation of the Food and Drug Administration’s certification. Moreover, in response to the export needs of local manufacturers of biological drugs, articles concerning the operational workflow for biological drugs for export purpose were added. Furthermore, the inspection and sealing procedures were simplified, and text regarding supplementary submission of documents or postponed submission of documents was added in accordance with the actual operation of the Inspection and Sealing Regulations.

It is expected that this amendment of the Regulations will benefit the local manufacturers of biological drugs, allowing them to carry out the biological drug inspection and sealing procedures smoothly in order to promote the development of Taiwan’s biological drug industry, enhance the international competitiveness, and improve public interest as well as the public health.