How long does it take for the DMF review? If the documentation is insufficient, what is the procedure for the submission of the supplement?

刊登日期:2020-07-22  |  點閱次數 : 1262 次 
  1. 1. Please refer to the latest announcement "Ministry of Health and Welfare Food and Drug Administration Application Processing Times".
  2. 2. If a closed part is not submitted upon the application, the regulatory agency will provide a one-month period for administrative supplements. The application data will be reviewed while documentation is complete. The inquiry is only once. A two-month period is given for correction. If the applicant is not able to meet the deadline, a written statement should be submitted to support the application of an extension. The extended deadline is one month after the expiry date of the original correction period. Only one extension will be allowed. If the deficiencies are not resolved to meet TFDA's satisfaction within the specified time period, the TFDA can reject the application. The applicant may appeal within four months after received agencies decision and which is limited to one time.


上一筆 For active pharmaceutical ingredients or active pharmaceutical ingredients of dru
下一筆 What are the requirements of official documents to authenticate the drug substanc