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Regulations

FAQ

Generic Drug

  • Q41

    Both 3.2.S.5 and 3.2.P.6 are locations for providing the information of reference standards or materials. If the information is included in 3.2.S.5, should information on all reference standards or materials be included in 3.2.P.6 again?

    In 3.2.P.6, a reference standard cited in 3.2.S.5 can be cross-referenced in 3.2.P.6, where considered appropriate. However, information on the reference standards or materials only used for the analysis of the drug product should all be included in 3.2.P.6.

  • Q42

    In which section should the description of overfill for injections be presented?

    The description of overfill for injections should be presented in 3.2.P.1 (description and composition of the drug product) and the justification should be included in 3.2.P.2.2.1 (formulation development).

  • Q43

    In which section should the stability protocol and report be presented?

    The summary and estimated shelf-life of the stability protocol and report should be included in 3.2.P.8.1 (stability summary and conclusion). The post-approval stability protocol and stability commitment should be included in 3.2.P.8.2 (post approval stability protocol and stability commitment). The stability data should be included in 3.2.P.8.3 (stability data).

  • Q44

    What information is required when in-house dissolution conditions are used, and in which section should the information be presented?

    If the in-house dissolution conditions are used, the justification (e.g. dissolution development report) should be provided in 3.2.P.2.2.1 Formulation Development.

  • Q45

    In which section should the validation report of quantitative method for dissolution profile comparison be provided?

    The validation report of quantitative method for dissolution profile comparison should be presented in 3.2.P.5.3 (validation of analytical procedures).

  • Q46

    For generic drugs in which BE (or dissolution comparison) was conducted domestic, the above report and CMC package were reviewed separately. When should study report of BE (or dissolution comparison) in CTD format be submitted?

    Although the study report of BE (or dissolution comparison) and CMC package are reviewed separately, sponsor can submit at the same time or separately. TFDA will process the application according to the internal processes.

  • Q47

    When dissolution profile comparison has been used to waive bioequivalence requirements for lower or higher strengths of a dosage unit, how the Module 5 package should be provided?

    When dissolution profile comparison has been used to waive bioequivalence requirements for lower or higher strengths of a dosage unit, the dissolution profile comparison report could be presented in Module 3.2.P.2.2.1 Formulation Development instead of in Module 5.

  • Q48

    Which section is recommended to present the information related to clinical study (ex. BA/BE study report) in CTD format?

    The information related to clinical study (ex. BA/BE study report) is recommended to be presented in Module 5.3.1.1 or Module 5.3.1.2. Related requirement can be found in TFDA announcement "Regulation of Bioavailability and Bioequivalence Studies".

  • Q49

    Which section is recommended to present the bioanalytical method report and validation report of the clinical studies?

    The bioanalytical method report and validation report of the clinical studies could be included in clinical study report or presented in Module 5.3.1.4.

  • Q50

    Where can the references for the CTD format be downloaded?

    The references for the CTD format can be found on the following websites: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_QAs.pdf http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4_Quality_Questions_Answers_R1.pdf
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