The application for a investigational new drug (IND) clinical trial protocol must include the documents specified in the "Notices for Clinical Trial Application " announced by the Taiwan Food and Drug Administration (TFDA). 
The subsequent content will provide an overview of the application process for a clinical trial. For the latest announcements, please visit the website of Pharmaceutical Regulations in Taiwan.

I.        Applicant Eligibility:

 (I)        The applicant must be a pharmaceutical firm or a teaching hospital qualified by the Ministry of Health and Welfare in conjunction with the Ministry of Education.

 (II)  The principal investigator, co-investigator, and trial personnel shall be qualified by training and shall comply with Good Clinical Practice (GCP). Both the principal investigator and the co-investigator must meet the qualifications specified in Article 4 of the Regulations on Human Trials.

II.   Application Procedures and Required Documents:

To apply for the review of a clinical trial protocol, applicants must submit an official letter stating the purpose of the application and the details of the trial protocol, including the name of the trial site, principal investigator(s), the study title with the protocol number, the countries participating, and whether the trial is for registration or academic research purposes. The document should list the contents of the submitted files and the version dates of each document. All documents must comply with the Notices for Clinical Trial Application announced by the TFDA. The application should be submitted through the Online Application Platform (ExPRESS), and the fee must be paid.

I.        Contact Information:

II.        Flowchart for Clinical Trial Protocol Application and Review:

Note:

(I)             Supplements or amendments for deficiencies should be submitted not later than 14 days after the issued date of the deficiency notice and the request for an extension is not allowed. If an applicant fails to make a response within the deadline, the central health competent authority can reject the application based on the currently available information.

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