To ensure the traceability and safety of regenerative medicinal products throughout the processes of manufacturing, importation, sale, and clinical use, the Ministry of Health and Welfare, pursuant to the authorization under Article 18, Paragraph 2 of the Regenerative Medicinal Products Act, has promulgated the Regulations on Sources and Destination Data Retention for Regenerative Medicinal Products (the “Regulations”) on October 28, 2025 by Order Wei-Shou-Shi-Zi No. 1141419964. Comprising a total of eight articles, the Regulations set forth requirements applicable to pharmaceutical companies and medical institutions regarding the scope, retention period, and inspection of records relating to the source, destination, and related information of medical products.

Specifically, under Article 2 of the Regulations, holders of drug licenses or conditional approvals are required to retain information on the active ingredients of each regenerative medicinal product (including tissue or cell tracking codes, and the name and country of the manufacturer), as well as destination information (including recipients, quantities supplied, and delivery dates). In addition, where tissue or cell donors are involved, further manufacturing or importation information shall be retained (such as the production volume, customs declaration dates, and expiration dates). These requirements are intended to enable the rapid tracing of patients and product sources in the event of safety concerns.

Furthermore, pursuant to Articles 3 and 4 of the Regulations, other distributors and medical institutions are also required to retain records of supply sources and destination information. Medical institutions, in particular, shall record the names of patients using such products, their national identification numbers or other identification document numbers, and contact information, so as to ensure comprehensive follow-up and traceability.

With respect to record retention periods, Article 5 of the Regulations provides that pharmaceutical companies shall retain the relevant records for at least thirty years after the expiration date of the product. Medical institutions shall retain records for at least fifteen years from the date of use; where the product is used on a minor, the retention period shall be extended to fifteen years after the individual comes to age.

Lastly, under Article 6 of the Regulations, the competent authority may conduct inspections on a regular or ad hoc basis and may invite experts, scholars, or representatives from relevant agencies to participate, in order to ensure the accuracy and completeness of the retained records.

The promulgation of the Regulations establishes a foundation for transparency and safety management across the supply chain of regenerative medicinal products, enhances patient’s medication safety and the public health regulatory framework, and aligns Taiwan’s regulatory practice with international trends in regenerative medicine quality management.