For the application of bioavailability (BA), bioequivalence (BE), and dissolution profile comparison study reports, please refer to 藥品生體可用率及生體相等性試驗相關法規彙編the Compilation of Regulations on Bioavailability and Bioequivalence Studies announced by the Taiwan Food and Drug Administration (TFDA). For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan. The subsequent content will provide an overview of the process for submitting an application for the review of bioavailability, bioequivalence, and dissolution profile comparison reports.

I.       Categories of Bioavailability, Bioequivalence, and Dissolution Profile Comparison Study Reports required to be Submitted:

(I)         As required by the Regulations for Registration of Medicinal Products (Please refer to Attachment 3 of Article 39, Attachment 4 of Article 40, Attachment 10 of Article 43 of Regulations for Registration of Medicinal Products ).

(II)       As required by the regulations for post-approval changes. (Please refer to Article 46 of the Regulations for Registration of Medicinal Products and the letter dated December 11, 2023, the announcement No. 1121412317.

(III)     Deemed necessary for execution by the central competent health authority.

Other principles for applying for exemption from bioequivalence study can be referred to: Article 8 of the Regulations of Bioavailability and Bioequivalence Studies, a waiver request of a BE study for a nasal aerosol or a nasal spray product registration or its post-approval changes, the website of Pharmaceutical Regulations in Taiwan, Guidelines for Verification of Therapeutic Equivalence for Topical Dermatological Products, Guidelines for Verification of Therapeutic Equivalence for Gastrointestinal Locally Acting Drugs, and ICH M9: Biopharmaceutics Classification System-Based Biowaivers.

II.      Documents required for application:

(I)       To apply for the review of reports on bioavailability, bioequivalence, and dissolution profile comparison studies, the applicant must provide an official letter (stating the reason for the application, the application category, information on items with changes, etc.), complete the required forms listed below, and submit them through the Online Application Platform (ExPRESS)" and complete the payment.

(II)     To apply for the review of bioavailability study reports, please complete the "Bioavailability Study Report Application Form" and prepare the relevant documents as specified in the application form.

(III)    To apply for the review of bioequivalence study reports, please complete the "Bioequivalence Study Report Application Form" and prepare the relevant documents as specified in the application form.

(IV)   To apply for the review of dissolution profile comparison reports, please complete the "Dissolution Profile Comparison Report Application Form" and prepare the relevant documents as specified in the application form.

(V)     For the registration or post approval change of generic nasal inhalers and nasal sprays exempt from BE tests, please follow the guidelines specified in announcement No. 0980364817 dated December 31, 2009 and prepare the relevant documents.

(VI)   For applying for a BCS-based biowaiver, please refer to "ICH M9: Guideline on Bioequivalence Studies Based on the Biopharmaceutics Classification System", complete the "BCS-based Biowaiver Self-Assessment Form"  and the "Dissolution Profile Comparison Report Application Form", and prepare the relevant documents as specified in the application form.

I.         

I.           Contact Information:

II.           Flowchart for BA/BE/dissolution profile comparison

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.

The TFDA website > Business Section > Drugs > Clinical Trials (including BA/BE trials) Section > Clinical Trial Related Forms and List Statistics