No. Class Title
  91   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?

  92   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?

  93   New Drug Application (NDA)  

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

  94   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?

  95   New Drug Application (NDA)  

What are the review points for PK technical documents in a NDA submission (as a new chemical entity)?

  96   New Drug Application (NDA)  

Is there any point of view about developing IV bolus administered method in low oral bioavailability drug based on the result of animal study?

  97   New Drug Application (NDA)  

For the new drug applications of controlled release dosage form contained multiple dose strengths. Under the proportionally similar formulations of different dose strengths product and the known linear PK characteristics in IR product, is it necessary to perform a PK study in all different dose strengths?

  98   New Drug Application (NDA)  

Is it acceptable to submit a new drug application for a drug product involving two or more drug substance manufacturers?

  99   New Drug Application (NDA)  

If the drug substance is fermented by microorganisms (e.g., bacteria, yeast, fungi or microalgae, etc.), should the identification of microorganisms be provided?

  100   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?

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