Filing of 
Application  
Pre-evaluation of application  
Assignment of  Regulatory 
Reviewer s 
Regulatory 
Review  
Evaluation of 
Recommendations  
Clinical Trial 
Approval (CTA) 
/ Import License  
Approval (ILA)  Submission of 
Recommendations  Receipt of application  
(With C omplete Submission)  
FDA Payment  Pre-Assessment   Annex C 
 
Abridged  Clinical Trial Approval Process Flow Chart  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
*If the Regulatory Reviewers request for supplementary information from the applicant, the clock stops on the day the 
request is sent via email. Review will commence on the day the response is received.   Approved  Clinical Trial 
Disapproval  
No 
Yes Clarification 
on the 
Application  
End Applicant  
Center for Drug 
Regulation and Research  
Center for Drug 
Regulation and Research  
Regulatory 
Reviewers  
Regulatory 
Reviewers  
Center for Drug 
Regulation and Research  
Center for Drug 
Regulation and Research  Return to 
Applicant   
Acceptable  
*Clock Stops  Day 0  
Day 0  
Day 1 
Center for Drug 
Regulation and Research  Day 8 
Day 30 
Applicant  Day 9 
Day 22 
Day 23 Day 0  Center for Drug 
Regulation and Research  