TPKM/295
WTO/TBT
TW Taiwan
  • 11 - Health care technology
2018-01-26
2017-11-28

Medicinal products (biologic)

Draft of Cell and Gene Therapy Medicinal Product Management Act (10 page(s), in English; 8 page(s), in Chinese)

With cell and gene therapy medicinal products being commonly used to cure diseases all over the world, in order to safeguard the rights of patients and public health, the Food and Drug Administration (FDA), Ministry of Health and Welfare, proposes to enact "Cell and Gene Therapy Medicinal Product Management Act" to ensure the quality, safety and efficacy of cell and gene therapy medicinal products. Measures for implementing the Act will be drafted by FDA after the adoption of this Act.