Regulatory Strategy Consultations include BSE strategy consultation, NDA strategy consultation, ANDA strategy consultation, and consultation for drug development under the Animal rule.
In the drug development process, applicants with prepared BSE, NDA, and ANDA submission plans can communicate with the CDE proactively to reach a consensus on unclear parts before formal submission. This service focuses on discussing submission strategy issues and supportive technical dossier requirements for submissions.
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) Regulatory Strategy Consultations include BSE strategy consultation, NDA strategy consultation, ANDA strategy consultation, and Animal Rule consultation.
II. Application Documents:
Please provide the technical dossiers via email or CD to the project manager.
(I) To apply for NDA strategy consultation, please submit the NDA Strategy Consultation Form at the same time.
(II) To apply for BSE strategy consultation, please submit the BSE Strategy Consultation Form at the same time.
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.
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 timelines (calendar days) for Regulatory Strategy Consultations are detailed in the table below:
|
Consultation Item
|
Written Response
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Consultation Meeting
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Meeting Minutes
|
|
Regulatory Strategy Consultations
|
BSE strategy
|
Day 56
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Day 60
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Day 70 or 10 days after the meeting
|
|
NDA strategy
|
|
Complex ANDA Strategy Consultation
|
|
Animal Rule Consultation
|
|
General ANDA Strategy Consultation
|
Day 30
|
Day 34
|
Day 44 or 10 days after the meeting
|
Example: A BSE strategy 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.
