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  111   New Drug Application (NDA)  

How to establish the specification for drug substance?

  
  112   New Drug Application (NDA)  

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

  
  113   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?

  
  114   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?

  
  115   New Drug Application (NDA)  

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

  
  116   New Drug Application (NDA)  

What are the key considerations of preclinical review for NCE registration?

  
  117   New Drug Application (NDA)  

If there is a global generic drug which has been approved in A101 countries for over 10 years, however, its pharmaceutical composition has not yet been approved in Taiwan. What documents are required for drug registration?

  
  118   New Drug Application (NDA)  

How to find laws, acts, regulations, and announcements of drug registration？

  
  119   New Drug Application (NDA)  

How to register a drug with extended-release dosage form which has been approved in other countries, while the same ingredient with immediate-release dosage form has been approved in Taiwan? Is it regarded as a generic drug or a new drug? What documents are required for registration in Taiwan?

  
  120   New Drug Application (NDA)  

How to register an imported drug in Taiwan?

  
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