FAQ
All
No. Class Title
  51   Drug Substance  

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

 
  52   Drug Substance  

What are the requirements of official documents to authenticate the drug substance that has been approved by regulatory agencies in an abbreviated review for a DMF application?

 
  53   Drug Substance  

What documents should be submitted for a DMF application?

 
  54   Drug Substance  

Can the foreign manufacturer of a drug substance directly submit a DMF application in Taiwan without agents?

 
  55   Drug Substance  

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?

 
  56   Drug Substance  

Can different domestic agents submit DMF applications of the same drug substance from the same manufacturer?

 
  57   Drug Substance  

Can a drug substance from two or more manufacturers be submitted for a DMF application in one case, or separately?

 
  58   Abbreviated New Drug Application (ANDA)  

What requirements for contract analysis entity of drug products shall be met?

 
  59   Abbreviated New Drug Application (ANDA)  

Is there any clear description of domestic regulation regarding that the scale of process validation should be commercial scale, and it cannot be replaced by pilot scale?

 
  60   Abbreviated New Drug Application (ANDA)  

How the linearity and range for the validation of impurity test procedures in a drug product are determined?

 
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