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Regulations

FAQ

Generic Drug

  • Q21

    Where can the eCTD Builder be downloaded for the registration of generic drugs?

    Please refer to TFDA website: http://www.fda.gov.tw/TC/siteContent.aspx?sid=3223

  • Q22

    Are the hard copies of Module 1 required if the application is submitted via eCTD?

    If a document needs to be stamped or certified, for example, the application form, declaration, or certificate of pharmaceutical product, etc., in addition to the electronic files, hard copies of the original documents are required.

  • Q23

    Should the document of all sections in CTD format be included for the application of registration?

    The CTD format provides a harmonized structure and format for presenting information in a registration dossier, whereas administrative information and technical documents for different types of drugs are required according to “Regulations for Registration of Medicinal Products” and relevant regulations.

  • Q24

    Is it necessary to submit Common Technical Document (CTD) module 1 to 5 for the registration of generic drugs?

    Administrative information and technical dossiers are required according to "Regulations for Registration of Medicinal Products" and relevant regulations, and the files should be arranged in CTD format. At present, CTD Module 1 and Module 3 are required for the generic drug application. The requirement of CTD Module 5 for BA/BE study reports would depend on the case. It is recommended but not mandatory to provide CTD Module 2.

  • Q25

    CTD Module 2 is the summary of M3–M5. Can the information be cross referenced?

    CTD Module 2 is a summary and the information can be cross referenced. Currently, submission of Module 2 is not mandatory for generic application.

  • Q26

    During the review process in the registration of generic drugs, does the supplementary information also need to be presented in CTD format? How many copies are required?

    The supplementary information should be arranged in CTD format so that the formats of the supplementary information and the original application are consistent.

    If e-CTD is used for the preparation of the electronic supplementary information, submission of a CD is required. If the electronic supplementary information is prepared in CTD format (PDF files), and both of CMC and PK data are included in the supplementary information, the submission of 2 CDs is required. If the hard copies of the supplementary information are prepared in the CTD format, the CMC and PK parts of the supplementary information should be prepared according to modules and submitted accordingly.
     

  • Q27

    How should hard copies in CTD format be prepared?

    See the information on CTD format according to No. 1011405725 dated July 24, 2012 by the Department of Health.

  • Q28

    How should the hard copies of the documents in CTD format be prepared?

    It is recommended to use A4 (E.U. & Japan) or 8.5 × 11” (U.S.) paper, with holes punched on the left side. The content should be clear, and binding or punching should not damage the completeness of the content. Attach an adhesive tab or use a separating sheet to each independent document. Set the title according to the CTD checklist and label the sections in English or traditional Chinese. In addition, it is recommended to place a header/footer to indicate the section.

  • Q29

    What are the requirements for numbering the pages of a hard copy for CTD submission?

    For numbering the pages, please refer to the suggestions of ICH M4(R3) Organisation. Every individual document should be numbered starting at page one. (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf)

  • Q30

    How should content be presented if no information is available for a specific section in the CTD format?

    For items that are not required, the section should still be kept and stated that "no information", "attachment is not required" or "not applicable".

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