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 content provide applicants with information of post-approval package insert change. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

I.    The Type of Application Form
II.   Please refer to Article 63 of the Regulations for Registration of medical products for the required documents for package insert changes.

I.    Contact Information: 

II.     Flowchart for Post-Approval Package Insert Change Application:

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.

The TFDA website > Drugs > Registration Section > Application Area for Drug License Renewal and Change Registration > Related Forms Download