The MOHW announced on July 19, 2019 to change the “Checklist of the Administrative and Technical Documents Submitted for the Application of Generic Drugs” to the “Checklist of the Refuse-to-File (RTF) Mechanism for the Application of Generic Drugs”.   Submissions of ANDAs with serious deficiencies will be returned to the applicants with a partial refund.

In order to make the Checklist clear for both applicants and reviewers to follow, the MOHW decided to revise the checklist. 

Upon receiving the applications of generic drugs or drugs subject to the “Guidelines on the Review and Approval of Instruction Drugs”, the MOHW will firstly check the submitted documents according to the Checklist.  If the submission is complete, the MOHW will proceed with the formal review.  If the submission has deficiencies which reach the refuse-to-file threshold, the MOHW will inform the applicant within 14 days of receiving the application.

According to the Fee Schedule for the Application of Drug review and Approval, the fees for the ANDA is NT$140,000 if the reference product is under surveillance and is NT$80,000 if the reference product is not under surveillance.  In the case of RTF, applicants will receive a partial refund of NT$120,000 if the reference product is under surveillance and NT$60,000 if the reference product is not under surveillance.  Applicants will have to pay the full fees again when making a resubmission.

Any comments or suggestions on the draft revision of the Checklist should be sent to the TFDA within 60 days from the issuance date of the announcement of the revision (March 31).

【2021-04-06/ TFDA Website】