萬國法律事務所

On June 4, 2024, Taiwan’s Legislative Yuan passed a third and final reading of the Regenerative Medicine Act (再生醫療法) and the Regenerative Medicine Product Act (再生醫療製劑管理條例). These changes aim to ensure the safety, quality, and effectiveness of regenerative medicine, and to protect patients’ rights to receive treatment.
 
Regenerative Medicine Act (再生醫療法)
 
The Act stipulates that medical institutions must complete human trials before executing regenerative medicine. The act allows for only two exceptions: treatments for compassionate use and regenerative technologies approved by the central government before the Act's passage.
 
Compassionate use is restricted to individuals with life-threatening or severely disabling diseases where adequate medicine, medical equipment, or techniques that are urgently needed in Taiwan.
 
Non-medical institutions practicing or advertising regenerative medicine may be fined anywhere from NT$2 million to NT$20 million. Medical institutions using regenerative medicine without completing human trials may be fined anywhere from NT$200,000 to NT$2 million.
 
The Act also formalizes the Guide on Moral Policies Involving Human Embryo and Embryonic Stem Cell Research (人類胚胎及胚胎幹細胞研究倫理政策指引), which prohibits the creation of embryos through artificial insemination for regenerative medicine research. It also prohibits the creation of chimeras, reproduction of embryos for research purposes, and creation or reproduction of hybrids with human reproductive cells.
 
Regenerative Medicine Product Act (再生醫療製劑管理條例)
 
The Act defines regenerative medicine products as formulations containing genes, cells, and their derivatives intended for human use. Pharmaceutical firms intending to manufacture or import regenerative medicine products must first apply for inspection registration and obtain drug permit license from the central government.