On April 28, 2026, the Thai Food and Drug Administration (FDA) issued two guidance documents and two application templates, clarifying the specific applicable procedures, submission requirements, and regulatory pathways for temporary facilitation measures concerning cosmetics. These measures were initially announced by the Thai FDA on March 23, 2026, in response to supply chain disruptions caused by the ongoing geopolitical situation in the Middle East, providing phased regulatory relief for health products including cosmetics.
Key Content of the Temporary Facilitation Measures
Based on the March 23 policy announcement and the April 28 guidance documents, the temporary facilitation measures mainly cover the following:
- Changes to raw material sources: Changes to raw material sources, solvents, or dosage forms are permitted without resubmitting a cosmetic notification, provided that the chemical structure, product quality, safety, and efficacy remain unaffected.
- Packaging changes: Adjustments to packaging form, type, and size are allowed in the event of supply shortages, provided that the alternative packaging meets equivalent or higher standards.
- Formula and packaging characteristic changes: Certain formula adjustments and packaging characteristic changes may be processed through the Fast Track or case-by-case review pathway.
Fast Track Mechanism
The Thai FDA has further outlined the specific arrangements for the Fast Track mechanism:
- A risk-based approach is adopted for evaluating change applications.
- Processing speed is 3 to 5 times faster than the standard procedure.
- Relevant operational guidelines and application forms are available for download from the Thai FDA official website.
Guidance Documents and Application Templates
The supporting documents include two guidance documents and two application templates, detailing the applicable conditions, operational procedures, and required submission materials for the temporary facilitation measures. The guidance documents take effect upon publication. Companies may select the appropriate change pathway based on their specific circumstances. Raw material source changes and packaging size changes that do not affect product safety and efficacy are exempt from re-notification; changes involving formula adjustments or packaging characteristic modifications require evaluation through the Fast Track or case-by-case review.
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