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Regulations

FAQ

CMC

  • Q21

    Is a new DMF application required when the API manufacturing site is changed?

    Based on Appendix 12 of the Regulations for Registration of Medicinal Products, post-approval changes is required if the manufacturing site is changed. Alternatively, the applicant can submit a new application.

  • Q22

    Is an application for DMF of a biological API required?

    The technical documents on the APIs of biologics should be included in accordance with the DMF Technical Document Checklist announced by TFDA via the Announcement DOH 1021401257. The DMF usually will be reviewed within the biological NDA.

  • Q23

    What are the requirements for applicants who may file an API registration?

    The applicants who file the API registration must meet the requirements of the Pharmaceutical Affairs Act for pharmaceutical firms.

  • Q24

    What documents should be submitted for registration of APIs?

    Please refer to the information indicated in Appendix 8 and 9 of the Regulations for Registration of Medicinal Products and “the Technical Document Checklist for registration of APIs” announced by TFDA via the Announcement DOH 1021400426.

  • Q25

    What documents should be submitted for abbreviated dossiers for registration of domestic APIs?

    Please refer to the Announcement DOH1001403285 for the technical document requirements for abbreviated dossiers. Official certificate (This is to certify the API had been reviewed and approved by EDQM, EMA, or any one of the A10 countries* listed in the Regulations for Registration of Medicinal Products. The certificate, indicating the API being used in pharmaceutical preparations issued from any one of the A10 countries, is also satisfied.)

  • Q26

    Is the application in abbreviated dossiers applicable for imported APIs as for DMF application and registration of API?

    Abbreviated review for the DMF application is not limited to imported or domestic APIs; however, abbreviated dossiers for registration of API is only applicable to domestic API.

  • Q27

    Should the technical documents be provided for imported APIs approved with registration licenses when applying for the DMF certificates?

    For the APIs that applied for registration before June 30, 2013 and had been granted a license, the relevant documents according to the Announcement DOH 1021401257 released on February 21, 2013 should be provided for DMF application.

  • Q28

    Can a domestic agent file two DMF applications for the same API manufactured by two different sources (manufacturers) at the same time? Is one application acceptable or would two applications be required?

    The domestic agent can file the registration applications for the same API from two different manufacturers at the same time, but two DMF applications must be filed separately.

  • Q29

    For those APIs approved with registration licenses, if needed, is there a specified time period for applying for post-approval changes of the API manufacturing process?

    At present, the deadline is not expressly stipulated for application of post-approval change of an API. However, the change of manufacturing process should be approved by the TFDA before selling.

  • Q30

    Is a GMP-related certificate required for the registration of an API?

    Yes, the GMP certificate of an API based on Appendix 8 of the Regulations for Registration of Medicinal Products is required.

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