IND Prior Assessment includes new clinical trial applications and appeals and is divided into quality parts, non-clinical parts, or full technical dossiers pre-assessment according to an applicant's needs.
Applicants can apply for an IND Prior Assessment of the technical dossiers of one or more professional sections (CMC, PT, PK/PD, statistical, and clinical) or all professional sections before formally submitting the clinical trial application.
I. Eligibility:
(I) Applicable to the following: domestic pharmaceutical/biotech companies, medical institutions, academia, CRO/consulting firms, foreign pharmaceutical/biotech companies, and pharmaceutical agents.
(II) Applicable product categories: drugs, bio-pharmaceuticals, and cell/gene therapy.
(III) IND Prior Assessment: including new clinical trial applications and appeals, divided into quality parts, non-clinical parts, or full technical dossiers pre-assessment according to an applicant's needs.
II. Application Documents:
Please provide the technical dossiers via email or CD to the project manager.
For IND prior assessment, please refer to "the Notices for the Application of Clinical Trials" and "Clinical Trial Protocol-Guidance on Technical Documents" to prepare the documents. Note that the documents do not need to be signed by the principal investigator. Please refer to the table below for a list of documents that are recommended to be provided:
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Quality (CMC/BIO) part
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Non-clinical (PT/
PT+PK) part
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Full technical dossiers
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1. Basic Case Data Form
2. Summary of Drug Clinical Trial Protocol Content
3. Chinese Protocol Synopsis
4. English Protocol Synopsis
11.Full CMC dossier in accordance with the " Clinical Trial Protocol-Guidance on Technical Documents."
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1. Basic Case Data Form
2. Summary of Drug Clinical Trial Protocol Content
3. Chinese Protocol Synopsis
4. English Protocol Synopsis
7. Investigator's Brochure
9. Full non-clinical, pharmacokinetic, and toxicological data in accordance with the " Clinical Trial Protocol-Guidance on Technical Documents."
10.For FIH trials, full reports of each nonclinical PK study and pivotal nonclinical safety study are necessary.
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1. Basic Case Data Form
2. Summary of Drug Clinical Trial Protocol Content
3. Chinese Protocol Synopsis
4. English Protocol Synopsis
5. Clinical Trial Protocol (with version and date; no PI signature required)
6. Informed Consent Form (with version and date; no PI signature required)
7. Investigator's Brochure
8. If a patient self-completed assessment scale is used, the validated Chinese version of the scale must be attached.
9. Full non-clinical, pharmacokinetic, and toxicological data in accordance with the " Clinical Trial Protocol-Guidance on Technical Documents."
10.For FIH trials, full reports of each nonclinical PK study and pivotal nonclinical safety study are necessary.
11.Full CMC dossier in accordance with the " Clinical Trial Protocol-Guidance on Technical Documents."
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III. Criteria for Case Acceptance :
Payment and submission of all required technical dossiers for the consultation case must be completed within the deadline.
IV. Other Instructions:
(I) The written responses and meeting minutes of the consultation will serve as important references for formal reviews. In the application letter to the TFDA, please summarize the consultation history and note the consultation case number as well as attach the written responses and meeting minutes.
(II) The CDE also offers customized consultation services. If an applicant needs this service, please indicate this in the consultation application form.
(III) Once a case is accepted, the CDE will not process any refunds or accept additional documents.
(IV) In the event of national holidays or force majeure, the CDE may extend the timeline.
The CDE reserves the right to modify these instructions at any time.
(I) First Stage - Strategic Discussion
1. An applicant fills out the Consultation Service Application Form on the CDE's website (https://www.cde.org.tw/).
2. The CDE contact person will notify the applicant of the consultation case number, the contact information of the project manager, and the payment method for the strategic discussion fee.
3. Applicants should provide electronic files of the technical dossiers to the project manager and pay the strategic discussion fee.
4. The CDE will hold a strategic discussion within 14 days after receiving the technical dossiers and the strategic discussion fee. With the applicant, the strategic discussion will also involve clarifying consultation questions and missing information as well as explaining the timeline and relevant fees.
5. For cases that have been evaluated and accepted, a quotation will be provided after the strategic discussion.
(II) Second Stage - Consultation Opinion Reply
1. Applicants should complete the payment of the consultation fee and submit a supplementary technical dossier within the quotation period of the consultation case. Once the supplementary information and the consultation fee have been received, the project manager will notify the applicant that the case has been accepted (Day 0).
2. The project manager will inform the applicant of the consultation case timeline via email on the acceptance day (Day 0). Each case will receive one written response and one consultation meeting to provide in-depth regulatory and scientific recommendations. The timeline (calendar days) for the IND Prior Assessment is as follows:
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Consultation Item
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Written Response
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Consultation Meeting
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Meeting Minutes
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IND Prior Assessment
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Day 30
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Day 34
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Day 44 or 10 days after the meeting
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Example: An IND prior assessment case is accepted on Day 0. The CDE provides a written response on Day 30. The consultation meeting is arranged on Day 34 (or a mutually agreed date). The applicant can submit questions for clarification before the meeting. If there are no questions about the written response, the consultation meeting can be canceled. The meeting minutes are provided on Day 44 or 10 days after the consultation meeting.
(I) Strategic Discussion Fee:
- The strategic discussion fee is NT30,000, which is deductible from the second stage consultation fee (subject to a maximum of one deduction per consultation case number).
- The case acceptance notice only includes the strategic discussion fee (it does not include a quotation for consultation fees, which is provided after the strategic discussion). Please pay the strategic discussion fee according to the case acceptance notice.
(II) Consultation Fee:
- Please refer to the schedule of fees announced by the CDE. A quotation will be provided after the strategic discussion.
- Applicants must pay the consultation fee within the validity period of the quotation. If the quotation has expired, the strategic discussion fee cannot be deducted.
