再生醫療製劑組織細胞提供者合適性判定辦法

The Regulations are prescribed in accordance with Paragraph 2 of Article 11 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”).

1The terms herein are defined as follows:

21. Eligibility determination: refers to the determination, based on the results of provider screening and provider testing, that a provider’s tissue or cells are suitable for use in the manufacture of regenerative medicinal products (hereinafter referred to as “products”).

32. Screening: refers to the evaluation and assessment of the presence or risk of contracting relevant infectious pathogens in a provider based on the provider’s medical records and medical history interview records, physical examination results, and other relevant medical records.

43. Testing: refers to the examination of relevant infectious pathogens or diseases conducted in a laboratory using specimens from the provider.

54. Suitable provider: refers to a person whose provider screening results show that the provider does not carry relevant infectious pathogens or have a risk of contracting disease, and whose provider testing results are negative or non-reactive.

1Manufacturers or importers of products (hereinafter collectively referred to as “pharmaceutical firms”) shall conduct screening, testing, and eligibility determination of providers of human tissues or cells.

2The screening, testing, and eligibility determination specified in the preceding paragraph may be delegated by pharmaceutical firms to other institutions (hereinafter referred to as “delegated institutions”).

3For the execution of the matters to be conducted under Paragraph 1 by pharmaceutical firms and delegated institutions specified in the preceding two paragraphs, standard operating procedures shall be established. A physician shall conduct a eligibility determination with at least one year of practical experience in cancer or cell therapy, basic or clinical immunology, cell banks, blood banks, or related regenerative medicine fields.

After screening and testing of a provider, if infectious pathogens or diseases listed in Appendix 1 are found, or if circumstances listed in Appendix 2 exist, the provider shall not be determined to be a suitable provider.

1When any of the following circumstances occur, tissues or cells obtained from the provider may not be subject to the restrictions of the eligibility determination results specified in the preceding article:

21. Medical needs of first-degree or second-degree relatives by blood.

32. Emergency medical needs.

4When circumstances specified in the preceding paragraph exist, pharmaceutical firms shall inform the medical care institutions using the product of the results of the eligibility determination, and the medical care institutions shall notify the patient and obtain written consent before the product may be used. The patient’s consent shall apply mutatis mutandis to the provisions of Paragraphs 3 through 5 and Paragraph 7 of Article 12 of the Act.

1When tissues or cells originate from newborns within one month of birth, the subjects of provider screening and testing are as follows:

21. Provider screening: the newborn and the biological mother.

32. Provider testing: the biological mother of the newborn.

4If specimen samples cannot be obtained from the provider’s biological mother for the execution of the testing specified in the preceding paragraph, the provider shall not be determined to be a suitable provider.

When tissues or cells are intended solely for the provider’s autologous use, a eligibility determination is not required. However, provider screening and testing must still be conducted, and the product label should indicate “For Autologous Use Only.”

Sampling of Specimens from the provider shall be conducted at the same time as the tissue or cell collection or within seven days before or after.

1Pharmaceutical firms or delegated institutions executing provider eligibility determination shall prepare a provider eligibility determination report, the contents of which shall include the following items:

21. Provider information.

32. Name, address, and date of determination of the institution conducting the provider eligibility determination.

43. Signature of the physician responsible for executing the determination.

54. Name and address of the laboratory unit conducting provider testing.

65. Results of infectious pathogen or disease screening and testing.

76. Judgment made regarding eligibility.

1Pharmaceutical firms shall retain the report specified in the preceding article for at least thirty years after the expiration of the storage period for products using the tissues or cells.

2The retention of records of screening and testing results conducted pursuant to the provisions of Article 7 shall apply mutatis mutandis to the provisions of the preceding paragraph.

When pharmaceutical firms or delegated institutions need to collect, process, or use personal information for the execution of matters specified in these Regulations, they shall comply with the provisions of the Personal Data Protection Act and relevant laws and regulations.

For human tissues or cells obtained by pharmaceutical firms or delegated institutions before these Regulations take effect, if eligibility determination has been made in accordance with the Standards for Donor Eligibility Determination of Human Cell Therapy Products and complies with the regulations, they may continue to be used for the original donation purpose after these Regulations take effect without needing to comply with these Regulations.

The Regulations shall come into effect on the day when the Act becomes effective.