Technical Dossier Evaluation on Drugs
Clinical Trials
Bioavailability/Bioequivalence Studies and Dissolution Profile Comparison Reports

Bioavailability (BA)/bioequivalence (BE) study, and dissolution profile comparison report applications should meet the requirements set forth in the Regulation of Bioavailability and Bioequivalence Studies announced by Taiwan Food and Drug Administration (TFDA), the Ministry of Health and Welfare. Please find more information about BA/BE study or dissolution profile comparison report submissions at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

Ⅰ. CLASSIFICATIONS
  1. BA/BE studies or dissolution profile comparisons should be conducted for drug products in such circumstances:
  2. 1. For a NDA application or as requested by the Regulation for Registration of Medicinal Products ; or
  3. 2. For a drug of which active ingredients are not on the list of post marketing surveillance but requested by the central competent health authority ; or
  4. 3. For an ANDA application of which active ingredients are on the list of post marketing surveillance (including the post marketing surveillance period has expired) ; or
  5. 4. For a drug product with post-approval changes:please refer to Articles 46 and 56 of the Regulations for Registration of Medicinal Products
  6. Criteria for a waiver of BE studies please refer to the Regulation of Bioavailability and Bioequivalence Studies.
Ⅱ. APPLICATION FEES
  1. Please refer to Standards of Review Fees for the Registration of Western Medicines.
Ⅲ. FORMS AND SUBMISSION REQUIREMENTS
  1. 1. For an application of a BA study report: Please complete “the Form of BA Study Report#1” and submit documentation in accordance with the requirements listed on the application form.
  2. 2. For an application of a BE study report: Please complete “the Form of BE Study Report#1” and submit documentation in accordance with the requirements listed on the application form.
  3. 3. For an application of a dissolution profile comparison report: Please complete “the Form of Dissolution Profile Comparison Report#1 “and submit documentation in accordance with the requirements listed on the application form.
  4. 4. For an application of a waiver request of a BE study for a nasal aerosol or a nasal spray product registration or its post-approval changes: Please complete “the Form of in Vitro Profile Comparison Report for Nasal Aerosols and Nasal Sprays#1” and submit documentation in accordance with the requirements listed on the application form.
  5. 5. For an application of a BCS-based biowaiver:Please refer to “the Guidance of Waiver of Bioavailability and Bioequivalence Studies for ANDA Based on a Biopharmaceutics Classification System”. An application must contain a complete “Biopharmaceutical Classification System (BCS)-Based Biowaiver #1” and “the Application Form for Dissolution Profile Comparison Report#1”. The documentation shall be submitted in accordance with the requirements listed on the application form.
    #1 The application form shall be authorized under the seal of the company and be submitted in an original copy.
Ⅳ. APPLICATION NOTICE
  1. 1. Number of Copies:A hard copy and an electronic copy of the BA/BE study report, including Form A and Form B.
  2. 2. Specifications:The hard copy should be printed on A4 paper with multiple punched holes on the left-hand side and be submitted in binders. The text on the paper should be clear and not be damaged due to binding or punching.
  3. 3. Binding and Packaging:
  4. (1) Please submit documentation in 2-ring or 3-ring binders. Documentation should be split into two or more binders if the submission is too large. It is recommended to attach a header on each binder with the drug name (Brand name / Generic name) and the name of the applicant.
  5. (2) Labels / Pagination: Please organize binders with color dividers and label with section titles on the right side of the page.
  6. (3) Please put the attachments in order of this reference: "the Regulation of Bioavailability and Bioequivalence Studies
  7. 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.)
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. 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.
  2. 2. 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.
  3. 3. 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