According to Article 46 of the Pharmaceutical Affairs Act, without approval of the central competent health authority, no alteration can be made to any of the originally registered particulars pertaining to any medicament approved for manufacturing or importation. In accordance with Paragraph 4, Article 39 of the Pharmaceutical Affairs Act, the application for the post-approval changes shall follow the requirements set forth in the Regulations for Registration of Medicinal Products.
The following resources provide applicants with information of post-approval changes in indications, drug administration and dosage. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

I.    Categories of post-approval change:
(I)    Changes in indications
(II)   Changes in drug administrations and dosages
II.    Documents required for application submission:
(I)    Please refer to Articles 54 and 55 of the Regulations for Registration of medical products 
(II)  The Type of Application Form.

(III)   The "Post-Approval Changes in Indications and Drug Administration and Dosage Refuse to File (RTF) Checklist" (Refer to the announcement No. 1131406955 dated June 18, 2024). For the data sheets and declaration forms mentioned in the RTF checklist, please refer to the following announcements：

1.    "Clinical Trial Data Sheet for GCP Inspection”(Refer to the announcement No. 1121414566 dated January 5, 2024)

2.    " Data Exclusivity and Domestic and Foreign Clinical Trial Data Sheet" (Refer to the announcement No. 1131406955 dated June 18, 2024)

3.    " Declaration form of the status of pharmaceutical patents " (Refer to the announcement No. 1091400039 dated January 15, 2020)

I.    Contact Information: 

II.    Flowchart for Post-approval Changes in Indications, Drug Administration, and Dosage:

Note:

(I)        If the applicant is not able to meet the deadline, a written statement should be submitted to support the application of an extension. The extended deadline is one month after the expiry date of the original correction period. Only one extension will be allowed.

(II)      If there are special issues requiring expert opinions after the technical dossier review, external experts or the Drug Advisory Committee will be consulted as needed.

(III)  If there are any questions regarding the content of the official letter, applicants can contact the project manager (PM) or apply for Review Related Consultation (RRC).

(IV)  For case review status, please visit the TFDA website > Drugs > Case review status.

(V)     To comply with the electronic drug regulation management, applicants should file or update the package insert information on the online platform upon receiving the draft approval of the package insert.

III. Consultation Services
The CDE has extensive knowledge of domestic and international regulations and years of review experience. We provide diverse regulatory consultation services for industry and research departments at various stages, from drug development to market entry. We welcome all applicants to utilize these services to prepare regulatory-compliant submission documents. For application details, please see Consultation Services.

For the review fees, please refer to Standards of Review Fees for the Registration of Western Medicines.

I.           The TFDA website > Business Section > Drugs > Registration Section > Application Guidelines and Checklists 

II.        The TFDA website > Business Section > Drugs > New Drug Section > New Drug Registration Section > Related Forms Download