Thailand FDA Enhances Drug Labeling and PIL Rules: New Testing Requirements for Household Medicines

On August 20, 2024, the Food and Drug Administration (FDA) of Thailand issued an important update to the guidelines for electronically submitted modern drug formula registrations, originally established on June 23, 2023. This update specifically revises the standards for labeling and patient information leaflets (PILs) across certain drug categories, aiming to streamline the registration process and ensure that consumer information is clear, accessible, and in line with international standards. This revision is expected to enhance the competitiveness of Thailand’s pharmaceutical industry and improve public access to essential medications.

The updated guidelines focus on refining the labeling and patient information leaflets for modern drugs by:

• Public User Testing for PILs: The update mandates that for household medicines, as well as drugs not classified as dangerous or under special control—including those recently downgraded from such classifications—the patient information leaflets must undergo public user testing.
• Testing Specifications: The user testing must be conducted on materials that exactly mirror the final product in terms of size, paper quality, color, and font style. A comprehensive test report must be compiled and submitted for the PILs.

This adjustment aims to ensure that the information provided in labels and PILs is clear, easily understood, and vetted by the public, thereby promoting self-care and disease prevention aligned with Thailand’s societal needs.

The update marks a significant shift for household medicines and other non-dangerous or non-special control drugs, particularly those recently reclassified. Pharmaceutical businesses are now required to conduct public user testing for PILs, ensuring that these informational materials meet public comprehension standards.

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