Technical Dossier Evaluation on Drugs
Bridging Study Evaluation(BSE)
Bridging Study Evaluation(BSE)

A Bridging Study Evaluation is carried out through evaluating the data of pharmacokinetics (PK)/ pharmacodynamics (PD), efficacy, safety, and dosage to evaluate whether the foreign clinical trial data can be extrapolated to the corresponding population in Taiwan. The BSE data can be used to support new drug applications and to reduce duplicate clinical trials. An applicant should submit documents in accordance with the requirements set forth in the Guidelines on Bridging Studies, and verify whether the drug is regarded as requiring a bridging study evaluation before submission. Please find more information at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATIONS
  1. 1. According to Article 22-1 of the Regulations for Registration of Medicinal Products, the following drug items are regarded as requiring a bridging study evaluation:
  2. (1) New chemical entities (NCE); or
  3. (2) Genetically engineered drugs, vaccines, plasma derivatives of new molecular entities, and allergen extracts of new molecular entities; or
  4. (3) Items announced by the central health competent authority as requiring a bridging study evaluation.
  5. 2. For drugs other than the listed above, whether an application of a bridging study evaluation is left to the discretion of applicants.
Ⅱ. APPLICATION FEES
  1. Bridging Study Evaluation:TWD 30,000
Ⅲ. FORMS AND SUBMISSION REQUIREMENTS
  1. An applicant should provide the following documents:
  2. 1. A cover letter and the bridging study data package ( electronic file should be provided)
  3. 2. Application category Form A and Form B
  4. 3. BSE checklist
  5. 4. The package insert in Chinese or English
  6. 5. Complete clinical data package (CCDP), including bridge data package (BDP), preferably with data on ethnic groups in East Asia.
  7. 6. Receipt for payment
Ⅳ. APPLICATION NOTICE
  1. 1. An applicant may submit requests for Regulatory Consultation Service to CDE to confirm the integrity of R&D strategy and completeness of documentation before applying the bridging study evaluation to TFDA.
  2. 2. An applicant shall submit a BSE application prior to or at the time of the application of the drug registration. A bridging study data would not be requested for those drugs that have been exempted from bridging studies by the central health competent authority. However, there should still be sufficient clinical data to justify drug efficacy and safety. 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.
  3. 3. Please provide one hard copy and one electronic copy.
  4. 4. Contact Information:
Type Recipient Address
New application/ Re-evaluation the Food and Drug Administration
(TFDA)
(A) National Biotechnology Research Park Building F
Address:Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)
(B) Joint Services Center
Address:No.161, Kunyang St., Nangang District, Taipei, 115-61, Taiwan (R.O.C.)
(C) The Center for Drug Evaluation (CDE)
Address:3F No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. R.O.C
Supplements/ Extension reques CDE
(Original copy)
The Center for Drug Evaluation (CDE)
Address:3F No.465, Sec.6, Zhongxiao E. Rd.,
Taipei 11557, Taiwan. R.O.C
TFDA
(Duplicate copy)
(A) National Biotechnology Research Park Building F
Address:Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei City 115, Taiwan (R.O.C.)
(B) Joint Services Center
Address:No.161, Kunyang St., Nangang District,
Taipei, 115-61, Taiwan (R.O.C.)
Ⅴ. BSE REVIEW PROCESS

  1. 1. An applicant may request a one-month extension if they are unable to respond to the deficiency letter within two months of the issuance date. The applicant should request in writing an extension before the requested response date. Please note the time extension can be requested only once.
  2. 2. Based on the principles of risk management, if there are specific matters after the technical review, TFDA / CDE will submit the application to the Drug Advisory Committee for discussions as needed.
  3. 3. An applicant may contact the project manager or submit requests for consultations via Consultation Services on Cases under Review if they have any question about the deficiency letter.
  4. 4. The review status may be inquired through the Status of the Application or the TFDA’s website https://www.fda.gov.tw/TC/cases.aspx
Ⅵ. FAQ