A bridging study is conducted to provide clinical study data such as pharmacokinetic/pharmacodynamic, efficacy, safety, administration, and dosage data relevant to the local population, allowing foreign clinical trial data to be extrapolated to the local population. This serves as the basis for drug registration in our country, reducing the need to duplicate clinical trials. To apply for a bridging study evaluation,applicants must submit the required documents according to銜接性試驗基準“Ethnic Factors in the Acceptability of Foreign Clinical Data”. Before applying, confirm whether the drug requires a bridging study evaluation. For the latest announcements, please check the website of Pharmaceutical Regulations in Taiwan. The following content will guide you on how to apply for a bridging study evaluation.

I.        According to Article 22-1 of the Regulations for Registration of Medicinal Products, except for drugs with relevant local clinical trial data to justify drug efficacy and safety in Taiwan, alone with pharmacokinetic data on ethnic groups in East Asia, the following drug items are subject to a bridging study assessment:

            (I)            New chemical entities and new biologics.

         (II)             Items announced by the central health competent authority as requiring a bridging study assessment.

*Drugs that received designations for treatment of pediatric or rare severe disease from the central health competent authority and cellular and gene therapy products are exempt from the bridging study assessment.

II.      Documents required for application:

For applicants submitting a formal application to the Taiwan Food and Drug Administration (TFDA) for a Bridging Study Evaluation, the application should include official letter , the purpose of the application, indication, dosage form, and dose, and should list the contents of the submitted documents, which must be prepared according to 銜接性試驗基準“Ethnic Factors in the Acceptability of Foreign Clinical Data”and submitted via the Online Application Platform (ExPRESS), along with the required fees:

           (I)       Official letter

         (II)       Type of Application Form

      (III)       Regulatory Information Form

      (IV)       Bridging Study Evaluation Checklist (Appendix E of Guidelines on Bridging Study)

        (V)       Complete Clinical Data Package (CCDP), including Bridging Data Package (BDP), preferably containing data on East Asian populations

      (VI)       Draft of the package insert

    (VII)       BSE self-assessment report, referencing the 銜接性試驗評估審查重點考量"Considerations of Bridging Study Evaluation" 

III.    Point to Notice

    (I)           A Bridging Study Evaluation can be applied for before the registration application or simultaneously with the registration application.

   (II)           For drugs that the central health competent authority has exempted from bridging studies, bridging study data would not be required. However, there should still be sufficient clinical data to justify drug efficacy and safety.

   (II)           If regulatory authority suggests that a bridging study should be conducted, the applicant should submit a protocol to the central health competent authority for its review and conduct the study upon receipt of the approval. After the bridging study is completed, the applicant must submit study reports to the central health competent authority for assessment.

I.        Contact Information:

II.    Flowchart for Bridging Study Evaluation 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.

III.        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.

"Consideration of Ethnic Factors in the Acceptance of Foreign Clinical Data" and " Q&A on Consideration of Ethnic Factors in the Acceptance of Foreign Clinical Data".