Taiwan marked a significant milestone in healthcare innovation as the Regenerative Medicine Act passed its final reading at the Legislature, positioning the country as a trailblazer in the field alongside Japan and South Korea. The Health Ministry hailed this legislation as a crucial step towards ensuring the safety and quality of regenerative therapies while upholding patients' rights to access advanced treatments.
Under the new act, medical institutions are mandated to conduct human trials before implementing regenerative therapies, with stringent regulations governing gene, cell, and tissue engineering preparations, storage banks, and sources. The legislation defines the scope of regenerative therapies and outlines the requisite qualifications for practicing physicians. Violations of the law, particularly instances where regenerative medicine poses serious harm to patients, can result in fines of up to $61,730.
DPP Legislator Chiu Yi-Ying emphasized that the enactment of the Regenerative Medicine Act paves the way for biotech companies to scale up the production of related medical equipment and supplies, benefiting public health at large. KMT Legislator Hsieh Yi-Fong highlighted the law's role in equipping doctors and patients with enhanced tools to combat rare and complex diseases, while empowering the Health Ministry to effectively oversee the regenerative medicine industry.
The Food and Drug Administration acknowledged the rapid global advancement in regenerative medicine and underscored the legislation's role in improving access to cutting-edge medical treatments. By providing clearer regulations, the law is expected to foster accelerated industry growth and bolster Taiwan's international competitiveness in the biotech sector. The FDA announced plans to develop sub-regulations to fortify the country's regenerative medicine preparation and management system, ensuring comprehensive oversight and compliance within the industry.
