Go Top

Clinical Trial and Bridging Study
  • Q61

    What kind of drug product needs to apply for bridging study evaluation (BSE) before registration? What information is required?

    According to the provisions of Article 22-1 of the “Regulations for Registration of Medicinal Products”, The following drug items are subject to a bridging study assessment:
    1.New chemical entities (NCE); or
    2. Genetically engineered drugs, vaccines, plasma derivatives of new molecular entities, and allergen extracts of new molecular entities; or
    3.Items announced by the central health competent authority as requiring a bridging study assessment.
    For drugs other than the two categories listed above, whether an application of a bridging study assessment shall be filed is left to the discretion of manufacturers. For applications without bridging study data, if the central health competent authority considers that a bridging study is necessary, the manufacturer is obliged to conduct a bridging study.
    When applying for a bridging study assessment, manufacturers should fill out the checklist for bridging study assessments and provide a complete clinical data package, preferably with data on ethnic groups in Asia.
    When submitting the application, please enclose (1) the application letter for bridging study evaluation, (2) Bridging Study Evaluation Self-Evaluation Form (Wei Shu Yao Tzu No. 0980325016 Order: Bridging Study Guidelines Appendix F dated July 9, 2009), (3) the complete clinical trial data of the product, and submit the application to the TFDA for review after paying the fees. 
  • Q62

    During the 5-year effective period of the administrative protection for the first manufacturer of an approved NDA, dose the second manufacturer planning to market the generic drug need to apply for bridging study evaluation?

    Yes. The so-called administrative protection refers to Article 22-1 of the “Regulations for Registration of Medicinal Products”: In a situation where a license is granted to a new drug with the submission of bridging study data, if in the next 5 years any generic manufacturer intends to manufacture or import generics with ingredients, dosage form and contents identical to this new drug, then the generic manufacturer should submit all required data and a bridging study report up to the standards set by the