What is the latest time to start a clinical drug trial after approval?

After a drug clinical trial is approved, it must commence within three years from the date of approval. If no subject has signed an informed consent form within these three years, the approval for the drug clinical trial becomes automatically invalid. If there is still a need to conduct the drug clinical trial, a new application must be submitted.

If the approval for a drug clinical trial has expired and the applicant wishes to continue the clinical trial, they must re-submit a drug clinical trial application and obtain approval again following the prescribed procedures.