Taiwan Clinical Trials | 台灣臨床試驗資訊平台

Q51

For ongoing clinical trials, is it required to submit an amendment application to the TFDA for change of the placebo batch number?

Submission of an IND amendment is not required. Issue a letter to notify the TFDA is acceptable.

Q52

For ongoing clinical trials, what else information is required in addition to the reports of CoA and shelf life of the drug if an amendment application for extension of the effective period of the study drug for additional 6 months is anticipated? After completion of the amendment application, can the effective period of the study drug that has been delivered to the trial institution(s) be changed to 24 months by re-labeling?

To extend the effective period of a study drug, submission of an amendment application is required. The submitted information shall include the stability test results of the extension.

In addition, the labeling of the study drug may be corrected by re-labeling, however, a complete and rigorous relabeling SOP is required. Moreover, the re-labeling operation shall be performed by professional staff who have received re-labeling-related training, in order to prevent inclusion of such operation in the material weakness list during future GCP inspection.

Q53

Regarding the Subparagraph 3 of Paragraph 2 of Article 38-2 of the Regulations for Registration of Medicinal Products, "For a multination, multicenter, phase III clinical trial, 80% of the enrolled subjects have to be Taiwanese or more than 10% of the total number of subjects need to be Taiwanese", what is the basis for determination of the number of subjects in a clinical trial?

The provisions of the Guidelines for the Registration of Medicinal Products only specify the number of subjects that can be assessed "in principle" and the final number of subjects needs to be determined on a case-by-case basis.

Q54

Can the application for phase II trial be submitted prior to completion of the closure report of the phase I trial or such application can only be submitted after data analysis is completed for the phase I trial?

The TFDA does not have regulations on when to submit the application for phase II trial and submission of such application prior to completion of the closure report of phase I trial is acceptable. However, if the design of the phase II trial is based on the preliminary results of phase I trial, the summary report of the preliminary results of phase I trial shall be included in the application for phase II trial or a brief description of the relevant data of phase I trial shall be included in the Investigator Brochure.

Q55

For investigational drugs in clinical trials, is annual DSUR submission to National ADR Reporting Center mandatory according to the public notice (Shu Shou Shi Zi No. 1021401633) announced by the TFDA designating National ADR reporting center as the affiliated organization for handling the ADR system?

For investigational drug in clinical trials, sponsors and hospitals need to report AE/SAE/SUSAR under GCP regulation, while submission of the DSUR is not required.

Q56

An ongoing clinical trial is about to be completed and the enrolled patients are scheduled to take part in different extension studies. Is it required to submit another IND application? Or the notification of the extension studies can be sent to the TFDA directly?

If the extension study is planned to be part of the main study, application of protocol amendment is required. If patients from multiple trials are going to be enrolled in the same extension study, a separate IND application shall be submitted to the TFDA.

Q57

Are there laws or regulations for recycling investigational drugs in clinical trials?

Recycling investigational drugs shall be in accordance with the standard procedures delineated in the trial protocol and set by the sponsor, and the competent authority only requires storage of the study drugs, control of the quantity of the study drugs, and preservation of the relevant records.

Q58

Does the TFDA have specific regulations on the format of the clinical trial reports?

Please refer to the “Structure and Content of Clinical Study Reports”. Regarding multinational, multicenter clinical trials, subgroup analysis for efficacy and safety results shall be performed on Taiwanese patients.

Q59

What kind of drug product needs to apply for bridging study evaluation (BSE) before registration? What information is required?

According to the provisions of Article 22-1 of the “Regulations for Registration of Medicinal Products”, The following drug items are subject to a bridging study assessment:
1.New chemical entities (NCE); or
2. Genetically engineered drugs, vaccines, plasma derivatives of new molecular entities, and allergen extracts of new molecular entities; or
3.Items announced by the central health competent authority as requiring a bridging study assessment.
For drugs other than the two categories listed above, whether an application of a bridging study assessment shall be filed is left to the discretion of manufacturers. For applications without bridging study data, if the central health competent authority considers that a bridging study is necessary, the manufacturer is obliged to conduct a bridging study.
When applying for a bridging study assessment, manufacturers should fill out the checklist for bridging study assessments and provide a complete clinical data package, preferably with data on ethnic groups in Asia.
When submitting the application, please enclose (1) the application letter for bridging study evaluation, (2) Bridging Study Evaluation Self-Evaluation Form (Wei Shu Yao Tzu No. 0980325016 Order: Bridging Study Guidelines Appendix F dated July 9, 2009), (3) the complete clinical trial data of the product, and submit the application to the TFDA for review after paying the fees.

Q60

During the 5-year effective period of the administrative protection for the first manufacturer of an approved NDA, dose the second manufacturer planning to market the generic drug need to apply for bridging study evaluation?

Yes. The so-called administrative protection refers to Article 22-1 of the “Regulations for Registration of Medicinal Products”: In a situation where a license is granted to a new drug with the submission of bridging study data, if in the next 5 years any generic manufacturer intends to manufacture or import generics with ingredients, dosage form and contents identical to this new drug, then the generic manufacturer should submit all required data and a bridging study report up to the standards set by the

Contact Us

CONTACT

聯絡我們

CONTACT

FAQ

Clinical Trial and Bridging Study

All Contents Copyright 2019 Center for Drug Evaluation (CDE),Taiwan/ This website is operated by Center for Drug Evaluation (CDE), Taiwan