China drug package insert accessibility guidelines for simplified, large-font and electronic versions have been issued by the Center for Drug Evaluation (CDE), a department of the National Medical Products Administration (NMPA). These documents aim to standardize the content and format of drug package inserts to ensure patient safety and accessibility as outlined in Announcement No. 142 of 2023.
The primary objective of these guidelines is to make drug package inserts more user-friendly, especially for elderly patients and those with accessibility challenges. Below we outline the key provisions:
Simplified Drug Package Insert Format Requirements:
- Content Consistency: The simplified version should be a condensed version of the approved full package insert, maintaining consistency in content and requirements.
- Enhanced Readability: To ensure patient safety and accommodate different reading needs, the guidelines encourage the use of larger font sizes, with a particular emphasis on font size four or larger.
- Clear and Bold Highlights: Critical elements such as titles, prompts, warnings, and key information should be highlighted with larger and bold fonts to enhance visibility.
Large-Font Drug Package Insert Format Requirements:
- The large-font format should align with the content and size specifications of the simplified version and include suitable adjustments for better readability, emphasizing the importance of legibility for diverse patient groups.
Electronic Drug Instructions Formatting Requirements:
- Content Consistency: Electronic drug instructions should align with the approved full drug package inserts in terms of content and format. Chinese characters are encouraged to be presented in “黑体” or “宋体,” while English and numerals should use “Times New Roman.”
- Device Compatibility: They should support zooming functionality to ensure accessibility on various electronic devices without significant font or format variations.
- Accessibility Features: Applicants are encouraged to use large fonts, icons, and high-contrast text to improve accessibility. PDF format is recommended for electronic drug instructions, while the use of image formats like JPG is discouraged.
- No Advertisements: Electronic drug instructions should not include advertising plugins or payment-related features, ensuring that patients and healthcare professionals can access comprehensive drug information without distractions.
These guidelines mark a significant step forward in improving drug instructions accessibility and safety for patients and healthcare providers in China. The drug package insert guidelines came into effect immediately upon publication on November 24, 2023. Marketing authorization holders are expected to make changes to drug instructions inserts and electronic versions accordingly thereby enhancing the quality and consistency of drug package inserts and drug instructions for patients and healthcare providers in China.
Read the original CDE announcement on China drug package insert accessibility guidelines issued.
Read our previous blog post on China chemical drug instructions and labels guidelines.
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