再生醫療製劑審查費收費標準

These Standards are promulgated pursuant to Paragraph 3 of Article 8 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”) and Article 10 of the Charges and Fees Act.

1For applications for registration and inspection of regenerative medicinal products and issuance of a pharmaceutical permit license or conditional approval pursuant to Article 6 of the Act, the review fees payable for each application shall be as follows:

2I. Gene therapy products, cell therapy products, tissue-engineered products, and combination products: 1,500,000 New Taiwan Dollars. Where applications simultaneously include products of different dosage strengths, an additional 250,000 New Taiwan Dollars shall be charged for each additional dosage strength.

3II. Regenerative medicinal products for export only: 30,000 New Taiwan Dollars.

4III. Applications submitted by the holder of a pharmaceutical permit license or conditional approval for products with the same ingredients but different dosage strengths: 250,000 New Taiwan Dollars.

1For applications for clinical trials, the review fees payable for each application shall be as follows:

2I. Clinical trial protocol: 60,000 New Taiwan Dollars.

3II. Clinical trial report: 40,000 New Taiwan Dollars.

4III. Amendments to clinical trial protocols:

5(1) Trial sites, principal investigators, or trial sponsors: 6,000 New Taiwan Dollars.

6(2) Protocol documents, manufacturing sites of investigational products, or investigational product documentation: 10,000 New Taiwan Dollars.

7For applications for, or inspections conducted ex officio by the central competent authority in accordance with the Good Clinical Practice (GCP) regulations for pharmaceuticals, the review fees for on-site inspections shall be as follows:

8I. Overseas inspections: 500,000 New Taiwan Dollars per country. The same fee shall apply to Mainland China inspections.

9II. Domestic inspections: 50,000 New Taiwan Dollars per trial institution.

1For applications to change the registered particulars of a pharmaceutical permit license or conditional approval pursuant to Article 7 of the Act, the review fees payable for each application shall be as follows:

2I. Addition of an active pharmaceutical ingredient manufacturer or finished product manufacturer: 250,000 New Taiwan Dollars per manufacturer.

3II. Addition of indications: 250,000 New Taiwan Dollars; where more than one indication is added, 500,000 New Taiwan Dollars. Where multiple dosage strengths of products with the same ingredients are applied for simultaneously, an additional 30,000 New Taiwan Dollars shall be charged for each additional dosage strength.

4III. Addition of dosage and administration: 250,000 New Taiwan Dollars. Where multiple dosage strengths of products with the same ingredients are applied for simultaneously, an additional 30,000 New Taiwan Dollars shall be charged for each additional dosage strength.

5IV. Transfer or merger of the holder of the pharmaceutical permit license or conditional approval: 30,000 New Taiwan Dollars.

6V. Package insert content: 30,000 New Taiwan Dollars.

7VI. Manufacturers engaged in contract packaging or labeling: 30,000 New Taiwan Dollars.

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For applications to change a permit license for products for export only, the review fee payable for each application shall be 10,000 New Taiwan Dollars.

For applications for extension of the validity period of a permit license pursuant to Article 8 of the Act, the review fee payable for each application shall be 10,000 New Taiwan Dollars.

For applications for reissuance of an approved copy of a permit license, conditional approval, package insert, label, outer carton, or aluminum foil packaging approval, the review fee payable for each application shall be 10,000 New Taiwan Dollars.

1For applications for certificates or approval letters relating to regenerative medicinal products, the review fees payable for each application shall be as follows:

2I. Certificate of Manufacture and Sale: 2,000 New Taiwan Dollars.

3II. Reissuance of approval letters due to loss: 2,000 New Taiwan Dollars.

4Applications for the certificates and approval letters referred to in the preceding paragraph shall be limited to three copies per application.

5Applications for the certificate referred to in Subparagraph 1 of Paragraph 1 shall be limited to one permit license per application.

1For written inquiries regarding matters related to regenerative medicinal products, the following fees shall be charged for each case:

2I. Determination of the regulatory classification of a regenerative medicinal product: 5,000 New Taiwan Dollars.

3II. Consultation on registration and inspection or clinical trials:

4(1) Where technical data are involved: 10,000 New Taiwan Dollars.

5(2) Where technical data are not involved: 5,000 New Taiwan Dollars.

6(3) Project-based consultation and guidance: 30,000 New Taiwan Dollars.

7III. Query of data from the Taiwan National Adverse Drug Reactions Reporting System Database: 5,000 New Taiwan Dollars.

1For applications for the following items, the review fees payable for each application shall be as follows:

2I. Determination of eligibility for special review mechanisms: 30,000 New Taiwan Dollars.

3II. Determination of life-threatening or severely disabling diseases pursuant to Paragraph 2 of Article 9 of the Act: 30,000 New Taiwan Dollars.

4III. Authorization for import under a pharmaceutical permit license or conditional approval: 4,000 New Taiwan Dollars.

5IV. Issuance, reissuance, or replacement of a permit license certificate: 1,500 New Taiwan Dollars.

6V. Convening consultation or advisory meetings: 30,000 New Taiwan Dollars.

7VI. Correction of errors in registration and inspection records or conditional approval particulars attributable to the manufacturer: 3,000 New Taiwan Dollars.

8VII. Importation of samples of regenerative medicinal products: 3,000 New Taiwan Dollars.

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1Pursuant to Paragraph 2 of Article 15 of the Act, for applications for advertisements recruiting tissue or cell donors for regenerative medicinal products, the review fees payable for each application shall be as follows:

2I. New application: 6,000 New Taiwan Dollars.

3II. Application for extension: 2,200 New Taiwan Dollars.

4III. Reissuance of approval certificate: 1,700 New Taiwan Dollars.

5IV. Written inquiries regarding advertising regulations: 2,800 New Taiwan Dollars.

6V. Written inquiries regarding health education advertising: 6,000 New Taiwan Dollars.

Where the central competent authority conducts overseas inspections pursuant to Paragraph 2 of Article 3, the on-site attendance fees for executing personnel and accompanying experts shall be charged to the inspected party in accordance with the standards prescribed in the Guidelines for Reimbursement of Overseas Business Travel Expenses.

These Standards shall enter into force on the date of enforcement of the Act.