西藥查驗登記審查費收費標準

These standards are promulgated pursuant to the provisions of Paragraph 2 of Article 104-2 of the Pharmaceutical Affairs Act, and Article 10 of the Charges And Fees Act.

1Review fees for each New Drug application are as below:

21. Registration for products of New Chemical Entities (NCE): TWD 1500,000.

32. Registration for products of new therapeutic compound or new administration route: TWD 500,000.

43. Registration for products of new dosage form, new dose unit, new unit strength or controlled release forms, new strength of the same therapeutic compound(s) and the same administration route: TWD 250,000.

5Review fees for each Generic Drugs and Drugs for Export Only application are as below:

61. Registration for generic drug products under pharmacovigilance: TWD 140,000.

72. Registration for generic drug products not under pharmacovigilance: TWD 80,000.

83. Registration for products for export only: TWD 30,000.

9Review fees for each Biological Drugs application are as below:

101. Registration for blood product, anti-toxin, or vaccine: TWD 1500,000.

112. Registration for gene-engineering biological product: TWD 1500,000.

123. Registration for approved biological drug with new dose package or new manufacturing site: TWD 250,000.

1Review fees for each Drug Clinical Trial application are as below:

21. Review of Investigational New Drug (IND) application: TWD 60,000.

32. Review of Investigational New Drug (IND) Clinical trial report (CSR): TWD 40,000.

43. Review of IND amendments (Including change of the medical institution or investigator and the sponsor): TWD 6,000.

54. Review of IND amendments (Including the protocol or protocol amendment, change of the investigational product manufacturer and the investigational medicinal product dossier): TWD 10,000.

65. Review of bridging study: TWD 100,000.

7Review fees for each Bioavailability (BA) and Bioequivalence (BE) studies are as below:

81. Review of a BA/BE study protocol: TWD 30,000.

92. Review of a BA/BE study report (including registration of products whose active ingredients are not under pharmacovigilance and changes of registered products): TWD 60,000.

1Review fees for each Active Pharmaceutical Ingredients (API) application are as below:

21. Registration or technical documents review of API for drug manufacturing purpose, each API or source, and new excipient: TWD 60,000; the upper limit is TWD 300,000.

32. Submission for importing raw materials for their own use, and submission for importing raw materials for trial-production: TWD 5,000.

43. The approval letter of API source of drug product, and the approval letter of the technical documents of the API: TWD 2,000.

54. The approvals extension of the technical documents of the API: TWD 3,000.

1Review fees for each Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Inspections for Western Medicines are as below:

21. GMP inspections for Domestic pharmaceutical manufacturer:

3(1) Inspection for new establishment, relocation, expansion, resumption of operation, or addition of a new active pharmaceutical ingredient, dosage form, process operation, medicinal product: TWD 120,000; Additional fee of TWD 20,000 will be charged whenever there is an additional dosage form, biological drug, or active pharmaceutical ingredient (limited to one additional dosage form, product or process operation per application).

4(2) Follow-up inspection: TWD 120,000.

5(3) Review of a pharmaceutical manufacturer which produces both drugs and non-medical products: TWD 20,000; Additional fee of TWD 5,000 will be charged for a shared promise whenever there is an additional product.

6(4) Review of contract analysis application: TWD 10,000; Additional fee of TWD 20,000 will be charged whenever onsite inspection is needed.

7(5) Change of the medicament manufacturing license: TWD 10,000; If only involving changes in the pharmacist in charge of the manufacturing: TWD 2,500.

8

1Review fees for each post-approval change and extension or reissue due to damage or loss of drug licenses are as below:

21. Site change or additional active pharmaceutical ingredient manufacturer of biologic drug, or biologic drug product manufacturing site change: TWD 250,000.

32. Change in new indication, new administration dosage, new category: TWD 250,000.

43. Change in contract manufacturing, place of production or manufacturing-site relocation: TWD 50,000.

54. Change in transfer or merger: TWD 30,000.

65. Change in package inserts according to the approved insert by A10 countries, which include Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden or clinical references: TWD 30,000.

76. Change in new indication, new administration dosage, package inserts according to the first approval: TWD 20,000.

87. Change in contract packaging or labeling place of production: TWD 30,000.

9

1Review fees for each Related certificates and reference letters are as below:

21. Free Sale Certificate (FSC): TWD 2,000.

32. GMP certificate: TWD 2,000.

43. GDP certificate: TWD 2,000.

54. Reference letter of clinical trial, BA and BE study: TWD 2,000.

65. Reissue of medicament manufacturing license, western pharmaceuticals distribution license, reference letter and approval letter: TWD 2,000.

7Applications of the certificates and reference letters listed in Subparagraph are limited to three copies per set for each application.

8Applications of FSC listed in Item 1 of Paragraph 1 are limited to one license for each application.

1Review fees for each Letter of inquiry are as below:

21. Inquiry about registration of drug (clinical trial included), classification of products and quality inspection of medicament manufacturer and western pharmaceuticals distributor: TWD 5,000.

32. Inquiry about registration of drug (clinical trial included), classification of combination products and technical documents review: TWD 10,000.

43. Inquiry about application of drug counseling project: TWD 30,000.

54. Inquiry about retrieving data from national adverse drug reaction database: TWD 5,000.

65. The application for priority review designation, accelerated approval designation, and breakthrough treatment designation: TWD 30,000.

1Review fees for each application are as below:

21. Application of the authorization for import or export of drugs: TWD 3,000.

32. Collection of a medicament license (initial issuance, reissuance and replacement included): TWD 1,500.

43. Consultation and counseling meeting: TWD 30,000.

54. The application for license related correction: TWD 3,000.

65. The importation for medicine which license is under extension or has been completed variation: TWD 10,000.

76. Application for import certificate of medicine: TWD 3,000.

87. The declaration for not importing medicine: TWD 3,000.

The cost of inspector(s) and experts when executing the jobs described in the Subparagraph 1 of paragraph 3 of article 3, Item3、4 of Subparagraph 2 of article 5 should be calculated based on the Guidance for Reimbursement for Overseas Traveling Expenses, and paid by the applicant to the central competent health authority.

These standards shall be implemented from January 1st, 2021.