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  81   Abbreviated New Drug Application (ANDA)  

Where should the stability protocol and report be presented?

  
  82   Abbreviated New Drug Application (ANDA)  

How many batch files of drug products are required for an ANDA?

  
  83   Abbreviated New Drug Application (ANDA)  

For ANDA registration, which section of CTD format should the batch analyses of the drug product be provided in? Should the analyzed batch be manufactured within 2 years?

  
  84   Abbreviated New Drug Application (ANDA)  

For ANDA registration, whether batch records from each packaging type should be provided, if there are different packaging types (e.g. Alu-Alu PTP blisters and HDPE bottles)?

  
  85   Abbreviated New Drug Application (ANDA)  

When applying the drug registration for a drug product, which contains the same active ingredient but different hydrate form of drug substance compared to the marketed drug product in Taiwan, is the submission for ANDA acceptable? If the salt form of the drug substance is different, is the submission for ANDA acceptable?

  
  86   Abbreviated New Drug Application (ANDA)  

How many batches are required for process validation after the registration of domestic medicinal product is approved?

  
  87   Abbreviated New Drug Application (ANDA)  

Are there any certifications required for pharmaceutical excipients in Taiwan?

  
  88   Abbreviated New Drug Application (ANDA)  

What are the requirements for the batch size of the batch manufacturing record (BMR) which is submitted for an ANDA?

  
  89   Abbreviated New Drug Application (ANDA)  

What are the requirements for acceptance criteria of residual solvents in a drug substance applied for a registration of a medicinal product?

  
  90   Abbreviated New Drug Application (ANDA)  

Shall batch analyses enclosed in the submitted dossier of imported drugs be performed domestically?

  
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