再生醫療細胞操作及細胞保存庫設置許可收費標準

The Standards are enacted pursuant to Article 7 and Paragraph 1 of Article 10 of the Charges and Fees Act.

1Medical care institutions or regenerative medicine biotechnology and pharmaceutical companies submitting applications pursuant to the " Regenerative Medicine Cell Operation Management Regulations" shall pay fees as follows:

21. New applications for a cell operation approval or substantial relocation of the operation site: NT$120,000.

32. Change to operation items or operational content:

4(1) Addition of operation items or operational content: NT$120,000.

5(2) Reduction of operation items or operational content: NT$10,000.

63. Change to operational areas:

7(1) Addition of manipulation rooms or change of designated use: NT$120,000.

8(2) Reduction of manipulation rooms: NT$10,000.

94. Extension of validity period: NT$120,000.

105. Changes of the name or address of the institution or the site: NT$10,000.

1Medical care institutions or regenerative medicine biotechnology and pharmaceutical companies submitting applications pursuant to the " Regenerative Medicine Cell Bank Establishment and Licensing Management Regulations" shall pay the fees prescribed as follows:

21. New application for cell bank establishment permit or substantial relocation of the operation site: NT$120,000.

32. Change to items preserved by the cell bank:

4(1) Addition of preservation items: NT$120,000.

5(2) Reduction of preservation items: NT$10,000.

63. Change to preservation areas:

7(1) Addition of areas: NT$120,000.

8(2) Reduction of areas: NT$10,000.

94. Extension of validity period: NT$120,000.

10

The Standards shall take effect on the date of the enforcement of the Regenerative Medicine Act.