Thai FDA Implements Submission Process for Screening Application Documents

Beginning August 1st, 2022, the Thai FDA implemented a new submission process (official announcement) that will provide an initial screening of the documents provided and a response within 15 days. The new process is applicable to all applications except for Class 1, which are auto-approved, and Fast Track applications. This comes as the TFDA implements updated processes, such as query response timelines, following the recent implementation of their new medical device regulations. This latest update addresses the initial steps the TFDA will take in the first 15 days after receiving a new application which includes Screening and Reviewing the application.  All Thai FDA applications must submitted through the e-Submission portal.

New Submission Process Overview

The process is similar to a pre-submission process but instead of confirming classification and/or grouping strategy, the TFDA’s Screening and Review will be focuses on the documents provided.

Step 1: Screening

The Screening step will check for the completeness of the documents according to the TFDA’s checklist (English). The documents uploaded must match the specified topics and if the documents are incomplete, the application will be rejected immediately. If the documents are complete, TFDA will allow the application to proceed to the Review step and the submission fee will be charged.

Step 2: Review

After the submission fee transaction has been completed, the application will be assigned to the Reviewer. During this step in the process, the reviewer will assess the documents for their correctness and evidence of safety and efficacy. Should the TFDA officer find incorrect or incomplete documentation, they will provide feedback and will allow the registrant to amend their documents in response to comments within 15 calendar days, 1 time. If the amendment cannot be made within the specified timeline, the application will be rejected. The 15 calendar days does not include any additional time required after the application has been submitted for approval by the authority as well as answering expert feedback should the application besubjected to an expert review.