FAQ
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No. Class Title
  231   Postapproval Changes  

For post-approval site change of biologics, how to determine the shelf life for drug product manufactured at the new site?

 
  232   Postapproval Changes  

For biologics, what information should be provided for the change involving a drug product manufacturer/manufacturing facility?

 
  233   Postapproval Changes  

What is the consideration to use side-by-side comparison or historical data comparison for comparability studies of biologics?

 
  234   HTA  

What is Health Technology Assessment (HTA)?

 
  235   HTA  

When do we need an HTA?

 
  236   HTA  

How was the dedicated HTA agency established in Taiwan?

 
  237   HTA  

What is assessed by the CDE HTA Division?

 
  238   HTA  

How does the HTA Division carry out assessments?

 
  239   HTA  

If the assessment reports from the UK, Canada and Australia are used as reference, do products that have undergone HTA or economic assessment in other countries need to be assessed locally?

 
  240   HTA  

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

 
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