BA or BE protocol applications shall 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 or BE protocol submissions at Rules and Regulations or visit the website Pharmaceutical Regulations in Taiwan.

1. According to Article 78 of the Medical Care Act and Article 7 of the Regulation of Bioavailability and Bioequivalence Studies, an applicant can conduct a domestic BA or BE study after the BA or BE study protocol is approved by the central competent health authority. For BA or BE studies of generic drugs, the protocol submission to regulatory authority for its review can be waived. For conducting BA/BE studies of anticancer drugs, please refer to the Announcement No. 1061404394. Due to the pharmacological effects of anticancer drugs (e.g. cytotoxicity) and the potential for serious side effects, the study population and the design of the BA/BE study should be under special considerations. If an applicant has any questions about the study design, please refer to the FDA Guidance” Product-Specific Guidance for Generic Drug Development”, the EMA Guidance “Product-Specific Bioequivalence Guidance“, etc. An applicant can consult with the Center for Drug Evaluation (CDE) via Regulatory Consultation Service to evaluate whether a study design meets regulatory requirements.

1. Please refer to Standards of Review Fees for the Registration of Western Medicines.

1. 1. An applicant shall submit a cover letter to state the rationale of the application and the information of the protocol including the name of the institution, the investigator(s), the protocol number, etc. The following documentation are required for BA/BE study protocol submission:
2. (1) For an application of a BA study protocol： Please complete “the Form of Bioavailability (BA) Study Protocol " and submit documentation in accordance with the requirements listed on the application form. Note that the application form shall be authorized under the seal of the company and be submitted in an original copy.
3. (2) For an application of a BE study protocol： Please complete the “the Form of Bioequivalence (BE) Study Protocol" and submit documentation in accordance the requirements listed on the application form. Note that the application form shall be authorized under the seal of the company and be submitted in an original copy.
4. 2. Before conducting a BA/BE study, an applicant shall register the BA/BE study on “BA/BE study registration" after Ethics Committee/ Institutional Review Board (IRB) approval. The registration information includes the basic profile of the study, the descriptions of the test drug and the reference drug, etc. The applicant must promptly update information if any relevant change occurs to ensure that the record is complete and accurate.

1. 1. Number of Copies：A hard copy and an electronic copy of the BA/BE study protocol, 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. 4. Please put the attachments in order of this reference：”The Form of Bioavailability (BA) Study Protocol "or” the Form of Bioequivalence (BE) Study Protocol ".
7. 5. Contact Information:

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2. 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.
3. 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.
4. 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