No. Class Title
  101   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?

  102   New Drug Application (NDA)  

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

  103   New Drug Application (NDA)  

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

  104   New Drug Application (NDA)  

What is primary reference standard?

  105   New Drug Application (NDA)  

How to establish the specification for drug substance?

  106   New Drug Application (NDA)  

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

  107   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?

  108   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?

  109   New Drug Application (NDA)  

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

  110   New Drug Application (NDA)  

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

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