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  151   Investigational New Drug Application(IND)  

What are the procedures for registration of clinical trials of human cellular products?

  
  152   Investigational New Drug Application(IND)  

Are there any restrictions on the qualifications of the trial investigators of clinical trials?

  
  153   Investigational New Drug Application(IND)  

Are there any restrictions on sites for conducting clinical trials in Taiwan?

  
  154   Investigational New Drug Application(IND)  

How long does the clinical trial review process take?

  
  155   Investigational New Drug Application(IND)  

Who is qualified to submit a clinical trial application?

  
  156   Investigational New Drug Application(IND)  

What is the review fee rate for the submission of clinical trial application?

  
  157   Investigational New Drug Application(IND)  

How to apply for an IND if a foreign company plans to conduct a clinical trial in Taiwan?

  
  158   Investigational New Drug Application(IND)  

What are the technical documents regarding Chemistry/Manufacturing/Controls (CMC), pharmacology/toxicology, pharmacokinetics and clinical data shall be submitted to support the clinical trial application in Taiwan?

  
  159   Investigational New Drug Application(IND)  

【ST】 Under what circumstances does the sponsor need to provide the current progress of the trial for a protocol amendment?

  
  160   Investigational New Drug Application(IND)  

【ST】What are the statistical review considerations for sample size estimation of a clinical trial?

  
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