To facilitate the research and development of cell therapy technology, Cell Therapy Technology Paid Consultations have been established by the CDE. Applicants can consult with the CDE before formally submitting cell therapy technology project applications. This mechanism aims to assist applicants in understanding technical dossier requirements during the planning stage, focusing on discussions of the requirements for cell therapy technology project proposals and CMC technical documents.

• Eligibility:
  • Eligible Applicants: Medical institutions and cell processing units (CPU)
  • Consultations include the following four categories:
    
    

    Category	Services
    Cell therapy technology project proposal pre-review (limited to Appendix Three)	Provides a pre-review before formally submitting the cell therapy technology project Topic discussion is not included.
    CMC technical document consultation	Consultation on specific topics related to cell manufacturing and control data
    Protocols for method suitbility in safety testing	Consultations on Sterility Test / Mycoplasma Test Protocols (charged per protocol)
    Patient informed consent in English for international medical care (including cell therapy technology instruction manual)	Approved cell therapy project applied to patient informed consent in English for international medical care (including cell therapy technology instruction manual)

    
    
• Application Process:
  • Applicants submit applications to the CDE: Fill out the Cell Therapy Technology Consultation Services Application Form online
  • Case acceptance notice: The CDE will provide the contact information of the project manager responsible for the case.
  • Submit technical dossiers: Electronic files of the technical dossiers should be sent to the CDE's project manager responsible for the case.
• 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.
• Other Instructions:
  • The written responses and meeting minutes of the consultation will serve as important references for formal reviews. In the application letter to the MOHW, please summarize the consultation history and note the consultation case number as well as attach the written responses and meeting minutes. 
  • The CDE also offers customized consultation services. If an applicant needs this service, please indicate this in the consultation application form.
  • Once a case is accepted, the CDE will not process any refunds or accept additional documents.
  • 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.

• First Stage - Strategic Discussion:
  • An applicant fills out the Cell Therapy Technology Consultation Service Application Form online at the CDE’s website (https://www.cde.org.tw/) .
  • 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. 
  • Applicants should provide electronic files of the technical dossiers to the project manager and pay the strategic discussion fee.
  • 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.  
  • For cases that have been evaluated and accepted, a quotation will be provided after the strategic discussion.
• Second Stage - Consultation Opinion Reply:
  • 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).
  • 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 paid consultation services are detailed in the table below:

• 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.
• 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.

Please fill out the Cell Therapy Technology Consultation Service Application Form online.