The new E-submission procedures consists of 2 stages:
Stage 1: Screening
The screening stage is a process of verifying the completeness of the documents according to the required checklist. In a scenario of incomplete documents, application will be rejected without any further consideration. In a scenario in which the documents are complete according to the required checklist, E-submission fee shall be proceeded. Consequently, the application will be transported to stage 2, the technical document evaluation stage.
Stage 2: Technical Document Evaluation
The technical document evaluation is the process of considering the validity of the submitted dossiers. In a scenario in which documents fail to comply with Thai FDA’s requirement, the authority will collect comments and revert registrant for amendment. The registrant is obligated to comply with the only one compliance within 15 calendar days. Application shall be rejected in case registrant comply with incomplete dossiers or fail to comply within the compliance deadline.
Figure 1: Flowchart of the New E-submission Procedures
Thailand FDA - New Procedures for E-Submission Application in Effect on August 1st, 2022