FAQ
Drugs
All
No. Class Title
  101   New Drug Application (NDA)  

When class 2 solvents are used in the manufacturing process of drug substance, what information should be provided if the absence of a routine test for class 2 solvents in the drug substance?

 
  102   New Drug Application (NDA)  

Is it acceptable to use an overage of a drug substance to compensate for degradation during a drug product‘s shelf life?

 
  103   New Drug Application (NDA)  

Should physicochemical properties of drug substance be provided in technical documentation of the drug substance?

 
  104   New Drug Application (NDA)  

Should the drug substance manufacturing process be provided in technical documentation of the drug substance?

 
  105   New Drug Application (NDA)  

What is primary reference standard?

 
  106   New Drug Application (NDA)  

How to establish the specification for drug substance?

 
  107   New Drug Application (NDA)  

What information should be provided if degradation product acceptance criteria in a drug product exceed the ICH Q3B qualification thresholds?

 
  108   New Drug Application (NDA)  

Should the quantity, materials and types of container for the drug product to be marketed in Taiwan be stated in label?

 
  109   New Drug Application (NDA)  

If an excipient of animal origin is used, such as gelatin or magnesium stearate, should a bovine spongiform encephalopathy (BSE) free certificate for the excipient be provide?

 
  110   New Drug Application (NDA)  

Which laws or regulations are related to Pharmaceutical Intellectual Property Protections in Taiwan?

 
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