Taiwan’s Legislative Yuan passed the “Regenerative Medicine Act” and “Regenerative Medicine Product Regulations” on June 4, 2024. These laws, collectively known as the “Regenerative Medicine Dual Acts,” were ratified by the President on June 19, 2024. They aim to establish a rigorous regulatory framework for the country’s developing regenerative medicine sector.
The legislation defines regenerative medicine as treatments involving genes, cells, and their derivatives. It promotes research and development through a dedicated committee and potential development incentives. Clinical trials are mandated for most applications, though exceptions exist for life-threatening conditions lacking alternative treatment. The laws also regulate the use of embryos and embryonic stem cells.
The regulations facilitate partnerships between medical institutions and biotech companies for cell-related operations. They manage tissue and cell sources through central authority approval and stringent donor consent rules. Enforcement includes strict oversight, with penalties of up to NT$20 million (616,000 USD) for violations.
Regarding regenerative medicine products, these regulations classify them as drugs under special provisions. Products are categorized into cell therapy, gene therapy, composite, and tissue-engineered categories. Manufacturers must employ qualified staff and adhere to rigorous production standards. Pre-market inspections and registration are mandated, with conditional approvals available for certain cases.
In addition, guidelines for donor assessments, consent procedures, and ongoing product safety monitoring are established. Penalties of up to NT$2 million (61,600 USD) are imposed for non-compliance.
The effective date of these acts will be determined by Taiwan’s Executive Yuan. Further regulations will detail implementation procedures. This regulatory framework marks a significant milestone for Taiwan’s regenerative medicine industry, aiming to ensure patient safety and foster innovation in medical technology.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.