On April 4, 2022, the TFDA updated their application query response policy aimed at expediting target application review times and clearing a backlog of open applications. The new policy also reduces the number of TFDA queries per application and the time applicants have to respond. The guidance also outlines new condition for which the TFDA will reject pending applications and require a new one to be submitted.

Previously, the TFDA would allow multiple rounds of queries per application with up to 30 days for the response. Under the new policy, it will be very important for manufacturers and their local partners to quickly answer questions and submit complete documentation.

This guidance will apply to applications submitted after July 1, 2022. Applications submitted before July 1, 2022 will be given one chance to respond within 30 days.

Below is a table outlining the new query response policies to be implemented July 2022.

Conditions for TFDA Applications Rejections

The new policy intends to expedite the review process and place more of the burden on the manufacturer and local license holder (Registrant). The TFDA will reject an application if any of the following occurs:

1. Registrant does not respond within a specified period of time (15 days for applications submitted after July 1, 2022 and 30 days if submitted before).
2. Registrant responds back with incomplete documents. The registrant will then need to prepare the documents and submit a new application.
3. The application has a status of “The registrant revises per the attachment” with which the process exceeds 200-300 days, as specified in the Notification of Ministry of Public Health below.
   • Class 1 MD submitted before Nov 12, 2021 and exceeds 200 days
   • Class 2 and 3 MD submitted before Sep 23, 2021 and exceeds 250 days
   • Class 4 MD submitted before Aug 4, 2021 and exceeds 300 days
4. The TFDA sent inquiries to the registrant before January 1, 2022, but the registrant has yet to respond (applicable from Jun 6, 2022)
5. Applications that were resubmitted with incomplete documents.

Rejected applications will need to be resubmitted and will need to repay the application fee of THB1,000 (~US$30).

TFDA Official Review Times for New Applications

As the TFDA looks to shorten their review times under the newly implemented regulations, it’s expected that they will begin enforcing these stricter policies to save their staff time. Below are the maximum amount of time the TFDA will take for the various registration routes available depending on the product’s classification.

The total review time is the amount of time from payment of the submission fee until issuance of the license.