To assist applicant in preparing ANDA registration dossiers that meet regulatory requirements before registration, the Center for Drug Evaluation (CDE) has established a ANDA Registration Consultation mechanism. This mechanism aims to facilitate effective communication between applicants and the CDE, reducing submission deficiencies and promoting a more efficient and effective review process.

Eligibility
An applicant should be a pharmaceutical company and have already submitted a ANDA registration

1. Application:
   An applicant fills out the Consultation Service Application Form on the CDE's website (https://www.cde.org.tw/).
2. Acceptance:
   Once the CDE confirms the application and fee payment, the applicant will be notified that the case has been accepted and the ANDA Registration Consultation will be in process. Applicants should provide electronic files of the materials to the project manager and pay the fee.
3. Response:
   First-Stage_Strategy Discussion: 
   The CDE will hold a strategy discussion within 14 days after receiving the technical dossier and the strategic discussion fee. The strategy discussion will involve both parties discussing the consultation strategy, clarifying, and screening consultation issues; the CDE will explain whether or not there is any missing information or documents in the technical dossier to be supplemented and provide a quotation after the strategy 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 timeline (calendar days) for the ANDA Registration Consultation is as follows:
   
   

   Consultation Item	Written Response	Consultation Meeting	Meeting Minutes
   General Generic Drugs	Day 30	Day 34	Day 44
   Complex Generic Drugs	Day 56	Day 60	Day 70

4. Other Instructions:

(I)  In the event of national holidays or force majeure, the CDE may extend the timeline.
(II) This mechanism provides one written response and one face-to-face consultation meeting. For further opinions, a new consultation application must be submitted as a new case. 
(III) The written response and meeting minutes will serve as important references for the review of registration.
(IV) The applicant will be notified the payment and recipt time after CDE receives the online application. Note that fees are non-refundable once paid.
(V) The CDE reserves the right to modify this explanation at any time if there are any unspecified matters.
(VI) This service is for the ANDA Registration Consultation. If needed, applicants can also apply for R&D Strategy Consultation

1. Strategy Discussion Fee: 
   The strategy discussion fee is NT$30,000, and it is deductible from the second phase consultation fee (subject to a maximum of one deduction per case number). No quotation will be issued for the strategy discussion fee. Please follow the notification to pay the strategy discussion fee and provide the payment proof (e.g., a scanned copy of the remittance slip) to the project manager to facilitate account reconciliation. 
2. Consultation Fee:
   (I) Please refer to the schedule of fees announced by the CDE. A quotation will be provided after the strategic discussion. 
   (II) 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.