The DMF is divided into two parts – an open (or applicant’s) part and a closed (or restricted) part. Which one is required for a DMF submission? Is it necessary to submit two parts simultaneously? Can the manufacturer of the drug substance submit the closed part directly to the TFDA after the applicant submits the open part to the TFDA?

刊登日期:2020-07-22  |  點閱次數 : 1684 次 
  1. 1. An open part and a closed part should be provided simultaneously for a DMF application.
  2. 2. If the closed part could not be provided simultaneously with the open part, the applicant may leave a note “The closed part will be submitted directly by the manufacturer of the drug substance.” on the cover letter while submission. Upon receiving the case number, the applicant should inform the manufacturer of the drug substance to submit the closed part to the CDE. The manufacturer has to inform the applicant and to ensure the case number shown on the package before delivery. 
  3. An example of labelling is as below:
    Name: CDE DMF Team (Case Number)
    Address: 3F., No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. R.O.C 
    Telephone: (02)8170-6000 #512
    Once the package is delivered, the applicant has to inform the regulatory agency about the delivery consolidator, tracking numbers, arrival date, and the manufacturer of the drug substance.


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