再生醫療製劑供應來源及流向資料保存辦法

The Regulations are prescribed in accordance with Paragraph 2 of Article 18 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”).

1The holder of a drug license or conditional approval for regenerative medicinal products shall maintain the following source and distribution records, respectively, according to the product’s drug license or approval number:

21. Information on the manufacture or importation of regenerative medicinal products:

3(1) For domestic manufacturers: each batch number and its production quantity.

4(2) For foreign importers: each batch number, its import quantity, and its customs clearance date.

5(3) The manufacturing date and storage period or expiration date for each batch number.

62. Information on active pharmaceutical ingredients of regenerative medicinal products:

7(1) Tissue and cell tracking codes.

8(2) The name, address, and country of the manufacturer of the active pharmaceutical ingredients.

93. Distribution information for regenerative medicinal products: for each batch number, respectively, the name, address, contact person and telephone number of the supply recipients, as well as the supply quantity and delivery date for each transaction.

10Where the manufacture of regenerative medicinal products does not involve tissue or cell providers, the preservation of data specified in Item 1, Subparagraph 2 of the preceding paragraph is exempted.

1Pharmaceutical firms engaged in the sale of regenerative medicinal products other than those specified in the preceding article shall maintain the following source and distribution records separately according to the license or approval number for the products they sell:

21. Information on regenerative medicinal products suppliers:

3(1) The supplier’s name, address, contact person and telephone number, as well as the batch number, quantity, and date for each purchase.

4(2) The manufacturing date and storage period or expiration date for each batch number.

52. Distribution information for regenerative medicinal products: for each batch number, respectively, the name, address, contact person and telephone number of the supply recipients, as well as the supply quantity and delivery date for each transaction.

1Medical institutions shall maintain the following source and distribution records separately according to the license or approval number for the regenerative medicinal products they use:

21. Information on regenerative medicinal products suppliers:

3(1) The supplier’s name, address, contact person and telephone number, as well as the batch number, quantity, and date for each purchase.

4(2) The manufacturing date and storage period or expiration date for each batch number.

52. Information on patients receiving regenerative medicinal products: according to each batch number, the name, National Identification Card number or identification document number, and contact information of the patients who received the product.

1Pharmaceutical firms shall maintain the records specified in Articles 2 and 3 for at least 30 years after the expiration date of the regenerative medicinal products.

2The records specified in the preceding article shall be maintained by medical institutions for at least fifteen years from the date of use. However, for use in minors, the records shall be maintained for at least fifteen years after they reach adulthood.

1The competent authority may conduct regular or irregular inspections in accordance with Article 22 of the Act.

2For the inspections mentioned in the previous paragraph, the competent authority may require pharmaceutical firms and medical institutions to provide source and distribution records for regenerative medicinal products, along with any supporting documents. The competent authority may also conduct on-site inspections, which pharmaceutical firms and medical institutions are required to facilitate without evading, obstructing, or refusing access.

3When the competent authority executes inspections specified in the preceding paragraph, it may invite scholars, experts, or representatives of relevant agencies (institutions) to participate.

When pharmaceutical firms and medical institutions need to collect, process, or use personal data in order to implement matters prescribed in the Regulations, the parties shall handle such matters in accordance with the Personal Data Protection Act and relevant laws and regulations.

These Regulations shall take effect on the date the Act enters into force.