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Regulations

FAQ

CMC

  • Q1

    When applying for registration of a pharmaceutical product, can the API be obtained from more than one source (manufacturer)? How should the application be made?

    For registration of a pharmaceutical product, the API can be obtained from more than one source. The comparison of CMC file of the new API source with that of the original source should be attached in the application materials submitted to the TFDA.

  • Q2

    Is one DMF application acceptable if an application is prepared in an anhydrous form and a hydrous form?

    No, the DMF applications should be submitted separately.

  • Q3

    Is it acceptable for the API with different particle size distribution to be in one DMF application?

    Yes, it is. Submission of two DMF applications is not required. The manufacturer should assess the market demand (if different particle size distribution has an effect on the dissolution of the drug product) and determine whether to submit an additional application.

  • Q4

    Is one DMF application acceptable if last manufacturing step of an API is produced by two or more manufacturers? Is an additional application required?

    In Taiwan, a DMF certificate is granted to an API with one manufacturer. In other words, each DMF certificate specifies only one manufacturer. APIs that are obtained from different manufacturers should be applied for different DMFs in separate applications.

  • Q5

    Can different domestic agents apply for DMF separately for the same API obtained from the same foreign API manufacturer?

    Yes, DMF certificate with different approval numbers will be issued to different applicants after approval.

  • Q6

    Is submission of a DMF application with complete technical documents required for those domestic APIs granted with API licenses according to the Announcement DOH 1021400426 released on February 21, 2013?

    1. Submission of technical documents can be exempted for domestic APIs’ licenses issued after 1996 and still effective, and the DMF certificate will be issued directly after paying the required fees. 
    2.  Application for the registration of domestic APIs and application for DMF can be submitted simultaneously. Additional fees are required, and the certificate will be issued along with the license.

  • Q7

    Is a complete technical document necessary to submit for a new applicant applying for an API DMF in which this API technical document produced by the same API manufacturer has been submitted by first applicant? Is there a simplified procedure?

    It depends on whether the first applicant has received the DMF certificate or not.
    1. If the first applicant has received the DMF certificate, the second applicant would submit the open part of the technical document together with an authorization letter issued by the API manufacturer, referring to the approved DMF certificate. In this case, submission of the closed part can be exempted.
    2. If the DMF application submitted by the first applicant is under review, the second applicant can attach the open part with an authorization letter from the API manufacturer, referring to the TFDA application number of the first applicant. In this case, submission of the closed part can be exempted.
    3. If the DMF application submitted by the first applicant was rejected, the second applicant needs to submit updated technical documents. Approval will not be granted if the submitted documents are exactly the same as those from the first applicant.

  • Q8

    Is there a grace period for the API manufacturer to provide the DMF closed part or information?

    There is no room for a grace period. The applicant should communicate with the API manufacturer to provide complete dossiers prior to submission.

  • Q9

    Does the TFDA accept the DMF application submitted directly by foreign API manufacturers?

    The TFDA does not accept the DMF application submitted directly by foreign API manufacturers for the time being. Those manufacturers must entrust a domestic agent or a drug product company to submit the DMF application.

  • Q10

    Is every item required in the DMF Technical Document Checklist announced by the TFDA? Can the applicant submit only the information that foreign API manufacturer willing to provide? Because some foreign API manufacturers only provide part of the information.

    The DMF applicant must prepare and submit all the information indicated in “the DMF Technical Document Checklist” announced by TFDA via the Announcement DOH 1021401257. If the foreign API manufacturer is not able to provide certain information, the reason(s) must be justified.
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