FAQ
Drugs
All
No. Class Title
  211   Botanical drug  

According to Chapter VI, section G of“Applicability of Combination Drug Regulations”published in 2016 US FDA Guidance for Industry “Botanical Drug Development”, is a botanical drug sourced from a single plant considered as a combination (due to different parts of a single plant) or not?

 
  212   Botanical drug  

If the claimed indication of botanical new drug is to add-on to other medication, what should be considered for nonclinical studies and from clinical/regulatory perspective?

 
  213   Instruction Drugs  

How to include the QR code for the imported drug products on the original carton to meet regulatory requirements?

 
  214   Instruction Drugs  

Is it allowed to apply for addition of tablet debossing patterns for the purpose of exportation for locally manufactured tablets already granted drug licenses?

 
  215   Instruction Drugs  

Is it necessary to apply for change for non-prescription drug products for dispensing in accordance with the format for labeling and package of OTC drugs according to the MOHW No. 1051402838 (announced on March 8, 2016)?

 
  216   Instruction Drugs  

All active ingredients of an instruction drug are listed in the "Guidelines on the Review of Instruction Drugs", but the contents of the active ingredients are not corresponded to this guideline. Can the post-approval change be submitted for the leaflet revision based on this guideline?

 
  217   Instruction Drugs  

What is the legal basis for the drugs containing active ingredients in line with "Guidelines on the Review of Instruction Drugs" following the regulations for generic drug registration?

 
  218   Instruction Drugs  

An instruction drug contains the active ingredient in line with “Guidelines on the Review of Instruction Drugs”. Is the document for registration submission of abovementioned instruction drugs required in CTD (common technical document) format? Is the content of the document required in accordance with “Regulations for Registration of Medicinal Products”?

 
  219   Instruction Drugs  

If an imported product that is regulated as a non-prescription drug in foreign countries, can it apply for a non-prescription drug in Taiwan? Which related regulations could be referred to?

 
  220   Application of Bridging Study Evaluation (BSE)  

What is the implication of bridging study waiver?

 
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