Technical Dossier Evaluation on Drugs
Drug Substances

An applicant of APIs shall submit the administrative and technical documents for review according to the “Guidelines on Drug Review and Approval”.  Upon the CDE’s receipt of an application, an administrative reviewer will be appointed to carry out an initial assessment of the administrative data according to the current “Guidelines on Drug Review and Approval”.  A review team consisting of experts in chemistry, manufacturing and controls (CMC) will be formed once an application passes the initial assessment.

During the review, if necessary, the applicant may be requested to provide additional documents.  The deadline for deficiency submission is two months.  If the specified deadline is unachievable, the applicant can apply for an extension of up to one month.  The final review report will be produced based on the review team.  The administrative reviewer in charge will go through the administrative approval procedure.  Please visit the TFDA’s website for the timeline for each type of applications.