The Center for Drug Evaluation (CDE) has developed the Module-Based Rolling Review mechanism to assist applicants in identifying possible deficiencies of the dossier(s) in the development stage and improves the quality of their submission.The concept of Module-Based Rolling Review is to submit modules of the Common Technical Document (CTD) dossier for pre-assessment rather than submitting full registration dossiers for review. Applicants can apply for a Module-Based Rolling Review of the technical dossier of one or more modules before the registration.

1. Eligibility:
   
   1. Applicants can submit technical dossier for any of the following modules in the CTD format: Module 3 (M3), Module 4 (M4), Module 5 (M5), or Module 5 (M5 BABE), to the CDE for application.
   2. Applicants should submit their application to the CDE at least six months before intended drug 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 module-based rolling review will be in process.
3. Response:
   
   1. The first review opinion will be provided on day 80 and applicants can provide additional documents based on first review opinion within 30 days. The applicants can ask for 30 days extension for preparing the additional documents.
   2. The CDE will provide second review opnion on Day 150 after reveiving additional documents from the applicants. 
      *Applicants can also request a face-to-face consultation meeting within two weeks after receiving the first or second review opinion if necessary.
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. This mechanism provides two written response and two face-to-face consultation meetings. If the applicant would like to seek further opinions, One should submit a new consultation application..
   4. The written response and meeting minutes will serve as important references for the review of drug registration.
   5. The CDE reserves the right to modify this explanation at any time if there are any unspecified matters.

1. Module 3 (M3): NT$300,000 per case
2. Module 4 (M4): NT$300,000 per case
3. Module 5 (M5): NT$1,050,000 per case
4. Module 5 (M5 BABE): NT$300,000 per case
5. Note: If the applicant submits more than two modules, please sum the fees for each module