For the application of bioavailability (BA) and bioequivalence (BE) study protocols, 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. 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 drug bioavailability and bioequivalence study protocols.

II.            Types of drug bioavailability and bioequivalence study protocols to be submitted:

(I)        According to Article 78 of the Medical Care Act and Article 4 of the Regulations of Bioavailability and Bioequivalence Studies, the bioavailability or bioequivalence study protocol (including pilot studies) conducted domestically must be approved by the central health authority before execution. The content of the study protocols must comply with the Regulations for Good Clinical Practice. However, bioavailability or bioequivalence study protocols for generic drugs may be exempt from prior application.

(II)      For the execution of bioavailability and bioequivalence study protocols for anti-cancer generic drugs, please refer to the notice from the Ministry of Health and Welfare dated May 25, 2017, the announcement No. 1061404394. Due to the pharmacological actions (e.g., cytotoxic effects) and potential severe side effects of anti-cancer drugs, special considerations should be given to the study population and design of bioavailability and bioequivalence studies. If there are any doubts regarding the study design mentioned above, you may refer to the U.S. FDA's Product-Specific Guidance for Generic Drug Development, the EU EMA's Product-Specific Bioequivalence Guidance, and the Center for Drug Evaluation's Product-Specific Guidance (PSG) CD03.2 and consult the Center for Drug Evaluation for advice.

II.      Documents required for application

To apply for the review of a drug bioavailability and bioequivalence study protocol, applicants must submit an official letter stating the purpose of the application and details of the study protocol, including the trial site, principal investigator, and protocol number. The document should list the content of the submitted files with the version date of each document. The completed documents must be submitted via the Online Application Platform (ExPRESS) along with the payment of applicable fees. To apply for the review of a bioavailability study protocol, please complete the Bioavailability Study Protocol Application Form and prepare the relevant documents as specified in the form.

(I)          To apply for the review of a bioequivalence study protocol, please complete the Bioequivalence Study Protocol Application Form, and prepare the relevant documents as specified in the form.

(II)        After the study protocol has been approved by the hospital's Institutional Review Board (IRB) and before the start of the trial, log in to the "BA/BE Study Protocol Registration Area" , and complete the registration of the study protocol summary, including basic information, test drugs, reference drugs, and study content, for record-keeping. If there are any changes to the registered BA/BE study protocol summary, please update it online promptly to ensure the completeness and accuracy of the registration information.

I.     Contact Information:

II.   Flowchart for BA/BE Study Protocols:

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 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 > Drug Clinical Trials (including BA/BE trials) Section > Drug Clinical Trial Related Forms and List Statistics