Thai FDA sets 30 September deadline for controlled drug distribution reports

What the notice says

On 1 September 2026, the Thai FDA Medicines Regulation Division (กองยา) reminded operators handling specified controlled drugs to submit production, import and sales data for May through August 2026 by 30 September 2026.

The reporting route depends on the operator and product. It may involve FDA Reporter, the pharmaceutical supply-chain Track and Trace system, or both. Applicable FDA Reporter forms include ภ.ค. 3, ผ.ย. 4, น.ย. 4 and ข.ย. 13. A submission is complete only after the responsible pharmacist approves it and the system issues a receipt number.

No activity does not automatically mean no filing. Depending on the case, licence holders may need to submit a confirmation of no production or import, or confirm no activity in Track and Trace. Sales reporting can still apply where inventory remained and sales took place.

Practical impact

Manufacturers, importers, wholesalers and sellers handling listed products should reconcile May–August transaction and inventory records before the deadline. A late mismatch can delay pharmacist approval or prevent the receipt number from being issued on time.

This is primarily a reminder for an existing reporting cycle, not a new product registration route. Thai FDA nevertheless states that failure to comply, or intentionally inaccurate reporting, may lead to action under applicable laws. The annexes to the official notice determine the exact products in scope.