FAQ
All
No. Class Title
  1   HTA  

How are pharmacoeconomic evaluations carried out? Are there any local reference or guideline?

  
  2   Abbreviated New Drug Application (ANDA)  

With regards to the eligibility of additional strength biowaiver in Item 3 of dissolution profile comparisons documentation from PK section on the ANDA Refuse to File (RTF) checklist, what document is this item exactly check for?

  
  3   Abbreviated New Drug Application (ANDA)  

With regards to validation report and bioanalytical report in Item 3 and 4 of bioequivalence study documentation from PK section on the ANDA Refuse to File (RTF) checklist, how the applicant to confirm if the documentation meets the requirement?

  
  4   Drug Substance  

What documents should be submitted for the registration of a drug substance (API)?

  
  5   Abbreviated New Drug Application (ANDA)  

What information is required on the package inserts of a generic drug?

  
  6   Abbreviated New Drug Application (ANDA)  

How much is the user fee for a generic drug registration?

  
  7   Abbreviated New Drug Application (ANDA)  

How long does the registration of a generic drug take?

  
  8   Abbreviated New Drug Application (ANDA)  

What documents should be submitted for the registration of a generic drug?

  
  9   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be provided when submitting an application for a mixture of drug substance and excipient(s) (API mix)?

  
  10   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, with regards to item 7 on the Type III checklist which states “Are drug substance and intermediate specifications, analytical procedures and certificates of analysis provided?”, what information should be provided?

  
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