To assist applicant in preparing ANDA registration dossiers that meet regulatory requirements before submission, the Center for Drug Evaluation (CDE) has established a Pre-ANDA meeting mechanism. The goal of this mechanism is to help applicants to submit qualified applications through effective communication with the CDE, which may reduce deficiencies of submission and facilitate a more efficient and effective review process. The CDE provides two categories of Pre-ANDA Meetings, please find more information below.

1. This mechanism is divided into two categories:
   1. Category 1: The item is to assist applicant in ensuring that their dossiers comply with the "ANDA Refuse to File (RTF) Checklist" requirements.
   2. Category 2: The item is to assist the applicant in ensuring that their submission documents meet the CTD format and verify the consistency between the submission dossier and the self-assessment report of the CMC part. However, the assessment does not include assessing the validity or correctness of experimental conditions, raw data, etc..
2. Eligibility:
   
   1. Category 1: An applicant should be a pharmaceutical company prior to the planned ANDA registration.
   2. Category 2: An applicant should be a pharmaceutical company and apply for consultation at least 4 months prior to the planned 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 Pre-ANDA Meeting will be in process.
3. Response:
   
   1. Category 1:
      The CDE will review the documents and complete the assessments within 14 days and send a written response through email to the applicant.
   2. Category 2: 
      The CDE will complete the initial assessment within 5 days from the date of receipt. Upon acceptance, it proceeds to the second stage. The second stage involves providing feedback on consultation opinions. The CDE will complete the review opinion within 45 days. If the applicant has any queries regarding the review opinion, they can request a face-to-face consultation meeting within 7 days after receiving the response. For those who decide to convene consultation meetings, the CDE will hold the meeting on the Day 60 and provide the meeting minutes on the Day 75.
4. Notes:
   
   1. The applicant will be notified the payment and recipt time after CDE receives the online application. It should be noted that fees are non-refundable once paid.
   2. In the event of national holidays or force majeure, the CDE may extend the timeline.
   3. The CDE reserves the right to modify this explanation at any time if there are any unspecified matters.

1. Category 1: 
   
   1. Administrative/ Drug substance CMC technical dossier: NTD 10,000
   2. Administrative/ Drug product CMC technical dossier: NTD 10,000
   3. Administrative/ Pharmacokinetics (PK) technical dossier (Includes bioequivalence (BE) study reports or dissolution profile comparison reports): NTD 10,000.
      *If applicant apply for consultation on two or more items simultaneously, the fee is NTD 20,000.
2. Category 2: The preliminary assessment fee is NTD 5,000. If the case is accepted, the applicant should pay an NTD 20,000 in the second stage.