Following Section 44 of the Interim Constitution of 2014, the National Council for Peace and Order issued Order No. 77/2559 ("Order") to the Food and Drug Administration ("FDA") with the aim to increase the efficiency of the approval processes for healthcare products. The government has now approved 14 notifications prescribing the highest rates and the actual rates of the official fees to be collected from the business operators for the submission, review and approval processes of all healthcare products under their authority. It is expected that the FDA will announce these notifications soon and the new official fees will be effective immediately thereafter.
We will provide another update as soon as the announcement has been made.