FAQ
Drugs
All
No. Class Title
  91   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?

 
  92   Abbreviated New Drug Application (ANDA)  

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

 
  93   Abbreviated New Drug Application (ANDA)  

Are there any certifications required for pharmaceutical excipients in Taiwan?

 
  94   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?

 
  95   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?

 
  96   Abbreviated New Drug Application (ANDA)  

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

 
  97   Abbreviated New Drug Application (ANDA)  

We would like to import Japanese medicinal products. According to Japanese regulations described by Japanese manufacturers, if a shelf life of 3 or 5 years has been granted with sufficient long-term stability data in the first-approved drug application, the subsequent applicants of generic drug products can perform a 6-month study at the accelerated storage condition only. Long-term stability test is not required for the subsequent generic drug application in Japan. Will the regulation follow accordingly in Taiwan?

 
  98   New Drug Application (NDA)  

Currently in the EMA and USFDA bioanalytical guidelines, for the analysis of bioassays in some kinds of studies, an additional requirement to perform Incurred sample reanalysis (ISR) is required. How to perform the ISR and is it also required in Taiwan?

 
  99   New Drug Application (NDA)  

For new drug application for registration, is the pharmacokinetic data required to be accompanied with an analytical method validation report?

 
  100   New Drug Application (NDA)  

The non-innovator’s new drug application has been waived the bridging study. Why the bioequivalence or bioavailability studies of non-innovator’s new drug application is still needed to conduct?

 
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