On June 4th, Taiwan’s Legislative Yuan passed the Regenerative Medicine Act at its third reading. This legislation establishes a framework for the comprehensive management of regenerative medicinal products throughout their entire product life cycle, ensuring their safety, quality, and effectiveness. By doing so, it aims to foster industry growth and deliver significant benefits to patients.
The Regenerative Medicine Act includes 23 articles covering five major aspects:
- Defining and classifying regenerative medicinal products, regulating manufacturers, and overseeing the review and approval process.
- Allowing the issuance of drug licenses with additional conditions for products that treat or diagnose life-threatening or severely disabling diseases to satisfy unmet medical needs.
- Regulating the eligibility of tissue donors, donors' consent forms, recruitment advertisements, and regulations concerning the manufacturing and marketing of regenerative medicinal products.
- Overseeing post-market surveillance and the storage of product flow data to strengthen the monitoring of post-approval product quality and safety.
- Clarifying that drug relief provisions apply to regenerative medicinal products to protect patients' rights.
As emerging biotechnology advances rapidly and drives the development of regenerative medicine, the TFDA emphasized that the Regenerative Medicine Act will enhance access to advanced treatments and serve as the legal foundation for governing regenerative medicinal products. The TFDA will also formulate relevant sub-laws and sub-regulations to ensure comprehensive and complete governance.
【2024-06-04 / TFDA】
