The Regenerative Medicine Act passed its final reading at the Legislature on Tuesday, making Taiwan the third Asian country to enact legislation specific to regenerative medicine after Japan and South Korea. The Health Ministry called this legislation a major milestone that ensures the safety and quality of regenerative therapies and patients’ rights to receive treatment.
The act stipulates that medical institutions must carry out human trials before implementing regenerative therapies, and lays out regulations for gene, cell, and tissue engineering preparations, storage banks, and sources. It also specifies the scope of regenerative therapies, as well as the necessary qualifications of practicing physicians. Law violations, especially in cases where the implementation of regenerative medicine seriously harms patients, can subject violators to fines of up to NT$2 million (US$61,730).
DPP Legislator Chiu Yi-Ying (邱議瑩) pointed out that the passage of the Regenerative Medicine Act enables biotech companies to mass-produce related medical equipment and supplies to the benefit of public health. KMT Legislator Hsieh Yi-Fong (謝衣鳯) added that the law not only provides doctors and patients with better tools against rare and complex diseases, but also allows the Health Ministry to better manage the regenerative medicine industry.
The Food and Drug Administration (FDA) noted that the field of regenerative medicine has seen rapid development worldwide, and said the law will help to increase the accessibility of cutting edge medical treatment. According to the FDA, biotech companies will also benefit from clearer regulations, accelerated industry development, and Taiwan’s enhanced international competitiveness. The FDA stated their intent to draft sub-regulations that will complete the country’s regenerative medicine preparation and management system.