Clinical Trial Consultations: These include consultations on the design of Phase I to Phase IV clinical trials.
For product research and development still in the clinical trial stage, applicants can discuss with the CDE in advance to reach a consensus on unclear parts before submission. This service focuses on discussing clinical trial design and technical dossier requirements supporting the clinical trial.
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) Clinical Trial Consultations: these include consultations on the design of Phase I to Phase IV clinical trials.
II. Application Documents:
Please provide the technical dossiers via email or CD to the project manager.
For clinical trial consultation applications that involve discussion of trial design, please provide a protocol synopsis. Additionally, depending on the consultation questions, applicants may provide briefing documents and related attachments to the project manager.
III. Criteria for Case Acceptance:
Consultation questions must be clear. 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.
(V) Consultation fees for Phase I (including preclinical) and Phase II clinical trial consultation applications from academic research institutions and medical institutions are currently fully subsidized. Note that strategic discussions are not held. Please submit the signed fully subsidized consultation affidavit. The affidavit can be found here.
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 dossier 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 clinical trial consultation 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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Clinical Trial Consultation
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Day 56
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Day 60
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Day 70 or 10 days after
the meeting
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Example: A clinical trial consultation case is accepted on Day 0. The CDE provides a written response on Day 56. The consultation meeting is arranged on Day 60 (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 70 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.
