FAQ
Drugs
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No. Class Title
  151   Investigational New Drug Application(IND)  

If the drugs for investigational drug or active control/concomitant drug use have not been approved for marketing in Taiwan, are the certificates of analysis of drug substance, drug product and placebo/active control/concomitant drug submitted in an investigational new drug (IND) application?

 
  152   Investigational New Drug Application(IND)  

Are stability data required for the submission of an investigational new drug (IND) application?

 
  153   Investigational New Drug Application(IND)  

Is there a basis to set the acceptance criteria of the organic impurities in the specifications of drug substance and drug product for investigational new drug (IND) applications?

 
  154   Investigational New Drug Application(IND)  

What CMC data of active controls or concomitant drugs should be submitted for investigational new drug (IND) applications?

 
  155   Investigational New Drug Application(IND)  

How to check information regarding ongoing clinical trials in Taiwan?

 
  156   Investigational New Drug Application(IND)  

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

 
  157   Investigational New Drug Application(IND)  

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

 
  158   Investigational New Drug Application(IND)  

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

 
  159   Investigational New Drug Application(IND)  

How long does the clinical trial review process take?

 
  160   Investigational New Drug Application(IND)  

Who is qualified to submit a clinical trial application?

 
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