Thailand’s New FDA Notification on Controlled Health Products: Streamlining Import and Export Processes

Thailand’s Food and Drug Administration (FDA) is set to introduce a new notification regarding the control of health products, in collaboration with the Thai Customs Department. This initiative aims to modernize and streamline the processes for importing and exporting controlled health products, addressing current regulatory challenges and improving efficiency for all stakeholders.

The cornerstone of this new approach is the National Single Window (NSW) system, which will serve as a centralized database for controlled health products. The NSW is designed to facilitate data collection and exchange, reduce procedural complexities, enhance transparency, and ultimately save time and costs for both government agencies and business operators.

The draft notification, titled “Notification of the Food and Drug Administration on the Control of Health Products under the List of Controlled Goods Database of the Customs Department,” seeks to replace outdated regulations with a more comprehensive framework. Key objectives include updating current laws and regulations, reducing unnecessary burdens on businesses whose products are not classified as health products, and minimizing excessive bureaucratic processes and discretionary decision-making by officials.

One of the most significant changes in the draft notification is the introduction and expansion of exemption codes. The new “EXEMPT2” category covers various scenarios, including:

1. Drugs intended for use in science laboratories, analysis, or verification of diseases not directly related to human use.
2. Specific chemical compounds such as Lithium, Carbonate, Mannitol, Corn Starch, and Dextrin.
3. Materials intended for use in sports and entertainment.
4. Materials intended to produce dangerous household products.
5. Materials with specifications for industrial use outside of health product manufacturing.

The draft notification also introduces the “EXEMPT100” code, which is reserved for situations where system failures prevent the issuance of standard permits or licenses per invoice documentation.

Furthermore, the draft notification expands the existing “EXEMPT99” category to encompass a broader range of medical instruments and related items. This expanded exemption now includes components, materials, and spare parts of medical devices. Additionally, it covers materials intended for use in herbal products, as well as instruments or software designated for research purposes only.

These detailed exemption categories demonstrate the FDA’s efforts to create a more nuanced and flexible regulatory framework. By providing clearer guidelines on what products fall under various exemptions, the notification aims to reduce confusion and streamline the import/export process for businesses dealing with products that may have previously occupied regulatory grey areas.

The proposed notification demonstrates a more nuanced approach to regulating health products, acknowledging the diverse needs of different industries while maintaining necessary controls. It covers both import and export processes, providing a more holistic regulatory framework for the sector.

As part of the legislative process, the draft notification is currently open for public consultation until 30 July 2024. Following this period, it will undergo further review by the Thai Customs Committee and the Import and Export Division of the Food and Drug Administration.

This initiative represents a significant step forward in Thailand’s efforts to modernize its regulatory environment for health products. By leveraging technology and refining regulatory categories, the Thai FDA aims to create a more efficient, transparent, and business-friendly ecosystem while maintaining robust health and safety standards. The new system is expected to benefit a wide range of stakeholders, from pharmaceutical companies and medical device manufacturers to importers of specialized industrial materials and research institutions.

Key Takeaways:

1. The Thai Food and Drug Administration (FDA) and Customs Department are collaborating to implement a new system for managing controlled health products.
2. The National Single Window (NSW) system will be used to collect and exchange data on controlled health products, enhancing efficiency and transparency.
3. The draft notification aims to update regulations, reduce burdens on businesses, and streamline processes for both operators and officials.
4. The draft notification introduces new exemption codes (EXEMPT2 and EXEMPT100) and expands the EXEMPT99 category to cover more scenarios.
5. The draft notification covers both import and export processes, providing more comprehensive guidance for stakeholders.
6. Public hearings on the draft notification will be open until 30 July 2024, followed by internal discussions within relevant government bodies.

Author: Panisa Suwanmatajarn, Managing Partner.

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