Regulation of Vaccine Development in Taiwan

Dr. Mei-Fang Chen (陳美方)
Senior Reviewer
Division of Medicinal Products,
Food and Drug Administration,
Taiwan

ABSTRACT

In Taiwan, vaccine development, testing, and regulations follow a standard set of steps. First, it needs exploratory stage and preclinical stage to approve the safety and the desired immune response. After a successful Phase III trial, the vaccine developer will submit a NDA application to the TFDA. Based on the scientific evaluation of the product, TFDA will approve the vaccine. After approval, the TFDA will continue to monitor the vaccine including the inspection of manufacturing facility of the vaccine, phase IV trials, the vaccine adverse event reporting system, and the vaccine safety datalink.

Vaccine development is a long and complex process and involving a combination of public and private involvement. TFDA also provides the consultation services for the researchers. Consultation services help the researchers to solve the regulatory problems and facilitate the new vaccine development. In another aspect, global cooperation is also an important issue to reduce the approval time of vaccine.  TFDA has to establish personnel exchange mechanism with regulatory agencies for regulatory harmonization or convergence.

The content is authorized by Dr. Mei-Fang Chen on October 30, 2017.

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