Fee-charging Standards for Registration and Authorization of Regenerative Medicine Cell Operation and Cell Bank Establishment
2025-12-26
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Article 1
The Standards are enacted pursuant to Article 7 and Paragraph 1 of Article 10 of the Charges and Fees Act.
Article 2
Medical 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:
1. New applications for a cell operation approval or substantial relocation of the operation site: NT$120,000.
2. Change to operation items or operational content:
(1) Addition of operation items or operational content: NT$120,000.
(2) Reduction of operation items or operational content: NT$10,000.
3. Change to operational areas:
(1) Addition of manipulation rooms or change of designated use: NT$120,000.
(2) Reduction of manipulation rooms: NT$10,000.
4. Extension of validity period: NT$120,000.
5. Changes of the name or address of the institution or the site: NT$10,000.
1. New applications for a cell operation approval or substantial relocation of the operation site: NT$120,000.
2. Change to operation items or operational content:
(1) Addition of operation items or operational content: NT$120,000.
(2) Reduction of operation items or operational content: NT$10,000.
3. Change to operational areas:
(1) Addition of manipulation rooms or change of designated use: NT$120,000.
(2) Reduction of manipulation rooms: NT$10,000.
4. Extension of validity period: NT$120,000.
5. Changes of the name or address of the institution or the site: NT$10,000.
Article 3
Medical 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:
1. New application for cell bank establishment permit or substantial relocation of the operation site: NT$120,000.
2. Change to items preserved by the cell bank:
(1) Addition of preservation items: NT$120,000.
(2) Reduction of preservation items: NT$10,000.
3. Change to preservation areas:
(1) Addition of areas: NT$120,000.
(2) Reduction of areas: NT$10,000.
4. Extension of validity period: NT$120,000.
5. Change of the name or address of the establisher or the site of the cell bank: NT$10,000.
6. Change of the responsible person, medical director, or quality director of the establisher: NT$10,000.
1. New application for cell bank establishment permit or substantial relocation of the operation site: NT$120,000.
2. Change to items preserved by the cell bank:
(1) Addition of preservation items: NT$120,000.
(2) Reduction of preservation items: NT$10,000.
3. Change to preservation areas:
(1) Addition of areas: NT$120,000.
(2) Reduction of areas: NT$10,000.
4. Extension of validity period: NT$120,000.
5. Change of the name or address of the establisher or the site of the cell bank: NT$10,000.
6. Change of the responsible person, medical director, or quality director of the establisher: NT$10,000.
Article 4
The Standards shall take effect on the date of the enforcement of the Regenerative Medicine Act.