Center For Drug Evaluation,Taiwan

　　　CDE　is the window of Investigational New Drug (IND) submission and is responsible for IND review. A transparent and timely process is established to enforce the quality and efficiency of IND review. Where necessary, CDE will arrange face-to-face meetings or provide teleconference with the sponsor for the IND issues. CDE completes IND review within 20 calendar days and sends the recommendation to DOH. Most of the recommendations are adopted by Bureau of Pharmaceutical Affairs (BPA) which directly issues the administrative decision. A few cases may be processed to further discussion in Drug Advisory Committee.

IND Submission Checklists

(Translation from the Chinese checklists page 1 #PQT-03-21)

1. Application for Import Certificate

2. Pharmaceutical Company License

3. IND letter or IRB approval letter from other participating countries (if available)

4. IRB approval letter

5. Clinical Trial Application Form

6. Protocol with principle investigator's signature

7. Informed Consent Form with principle investigator’s signature (Chinese version)

8. Case Report Form and (draft version is acceptable)

9. SAE Reporting Form

10. Investigators' CV

11. Insurance certificate or indemnity letter

12. Investigator’s Brochure or product characteristics information

13. Certificate of Analysis and stability data

14. Registration Fee for registration trial

15. Chinese/English synopsis

16. Questionnaire, if completed by patient, the questionnaire must be in Chinese and be validated.

17. Amendment history

(translation for reference only,not an official list)

For full information please see 藥品臨床試驗申請須知附錄8