FAQ
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No. Class Title
  11   Abbreviated New Drug Application (ANDA)  

If submitted application contains a drug product packaged in various sizes of plastic bottles, are technical documents related to each packaging size of drug product required at the RTF stage?

 
  12   Abbreviated New Drug Application (ANDA)  

On the ANDA Refuse to File (RTF) checklist, Items 1 and 3 of CMC drug product section mentioned “pilot scale” in the definition about the size of representative batch. What does a pilot scale stand for?

 
  13   New Drug Application (NDA)  

When will the e-submission system be fully implemented for the new drug registrations and clinical trial applications?

 
  14   New Drug Application (NDA)  

Is there any facilitated regulatory pathway of drug registration in Taiwan?

 
  15   Drug Substance  

If only Class 3 solvents are used in themanufacturing process of active pharmaceutical ingredient (API) and the loss on drying (LOD) test result is more than 0.5%, should the Class 3 residual solvents be controlled individually?

 
  16   Drug Substance  

Is it allowed to use a nonspecific method such as loss on drying to control residual solvents in the active pharmaceutical ingredient (API) when only Class 3 solvents are used in the API manufacturing process?

 
  17   Drug Substance  

If a solvent used in drug substance manufacturing process may be contaminated with ICH Q3C class 1 residual solvents (for example., toluene or acetone may contain benzene), what information should be provided if routine analysis of class 1 solvent in intermediates or in final drug substance is expected to be waived?

 
  18   Drug Substance  

What information should be included in the DMF/API application data for a starting material that is commercially available?

 
  19   Drug Substance  

The long- term stability studies (25 ± 2 °C/60± 5%RH ) and the accelerated stability conditions are (40 ± 2 °C/75± 5%RH ) are performed using three drug substance batches. If the stability result of one of three batches has a significant change during the stability testing period in the accelerated studies, what actions should be undertaken? (“Significant change” for a drug substance is defined as failure to meet its specification.)

 
  20   Drug Substance  

Should all analytical methods listed in a drug substance specification be fully validated?

 
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