According to Paragraph 1 of Article 39 of the Pharmaceutical Affairs Act, the manufacturing and importation of drugs must be filed with the central competent health authority for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug license is approved and issued. The fourth paragraph of the same article also stipulates that applications for drug registration should follow the "Regulations for Registration of Medicinal Products ". The regulation stipulates the matters to be noted and followed for various drug registration applications. According to Paragraph 2 of Article 4 of the regulation, generic drugs are defined as pharmaceutical preparations identical to a drug already approved in Taiwan in the aspects of ingredients, dosage form, contents and efficacy. The subsequent content will provide an overview of the process for applying to a generic drug registration. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

Documents required for application submission

I.           The “Type of Application Form” and the “Regulatory Information Form”.

II.       The "ANDA Refuse to File (RTF) Checklist" and the " Declaration form of the status of pharmaceutical patents" (please refer to https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2978&id=37532the Announcement No. 1101407447 dated August 31, 2021 and the “Regulations on the Implementation of Patent Linkage for Western Medicines effective” dated July 1, 2019 [https://law.moj.gov.tw/LawClass/LawAll.aspx?PCODE=L0030103] and the announcement No. 1080025868].

III.   Please refer to Appendix 4 or Appendix 5 of the Regulations for Registration of Medicinal Products for the required documents.

IV.    If the toll-manufacturer has already obtained a permit for the drug with the same ingredients, relevant authorization and comparison data can be provided according to the announcement No. 1011406534 dated August 10, 2012.

I.    Aplicant can choose one of the following ways to submit an application for registration:
1.    Physical document submission: Prepare 2 copies of electronic data discs which comply with the the "CTD format" announced by TFDA, and submit primarily in PDF format.
2.    Online submission: Submit online through the Online Application Platform (ExPress) or via eCTD.

Note: For eCTD submissions, please comply with the relevant regulations of the announcement No. 1101411462. 

II.    Contact Information:

 III.    Flowchart for ANDA Application and Review:

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.

IV.    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> Drugs > Registration Section > Application Guidelines and Checklists 

II.        The TFDA website > Homepage > Business Section > Drugs > Registration Section > Generic Drug Related Regulations and Announcements > Generic Drug Section