Newsletter
The Ministry of Health and Welfare Promulgates the Phased Implementation Timeline and Methods for Full Electronic Structuring and Paperless Drug Package Inserts
In response to growing environmental awareness and technological advancements, Taiwan and the international community are increasingly using new technologies to improve the delivery and use of drug package inserts. On July 31, 2025, the Ministry of Health and Welfare (“MOHW”) promulgated the “Phased Implementation Timeline and Methods for Full Electronic Structuring and Paperless Drug Package Inserts” (“Announcement”), and following this Announcement, all drug package inserts in Taiwan will be fully digitized.
I. Progress on the Implementation of Electronic Structuring of Drug Package Inserts
To encourage the safe use of medications, the MOHW started introducing standardized package inserts for non-prescription drugs in 2015, gradually broadening these requirements. In 2021, the MOHW added Subparagraph 21 of Paragraph 1, Article 20 of the Regulations for Registration of Medicinal Products, requiring that package inserts for prescription drugs also adhere to a standard Chinese format. This amendment has largely standardized drug package inserts in Taiwan.
Furthermore, leveraging technological progress, the MOHW launched an electronic system for labels and package inserts in late 2021. This system enables healthcare providers and the public to quickly access vital medication details, keeping Taiwan in step with the global move towards digital pharmaceutical regulatory management. Since May 2022, the public can search existing electronic structured drug package inserts, and pharmaceutical companies have been required to upload or update inserts on the “Drug Package Insert Inquiry Platform” after any changes are approved, starting in May of that year.
According to the Announcement, the MOHW requires that all package inserts be fully digitized by the designated deadline. Recognizing that pharmaceutical companies need time to update existing package inserts, the MOHW will implement this in phases.
Phase 1 (by December 31, 2025) — Complete Electronic Structuring and Database Entry of Package Inserts
Marketing Authorization holders (for both prescription and non-prescription drugs) who have not yet formatted and electronically structured their package inserts must do so through self-initiated changes and upload them to the “Drug Package Insert Inquiry Platform.” It should be noted that the original approved text content cannot be altered during this process.
Phase 2 (by December 31, 2026) — Full Adoption of Formatted and Electronically Structured Package Inserts
II. Paperless Drug Package Inserts
Following this Announcement, drug package inserts will transition fully to a paperless format once electronic structuring is complete. However, to ensure medication safety and address the needs of healthcare professionals, the MOHW has also announced “Guidelines on Paperless Drug Package Inserts” (“Guidelines”). According to the Guidelines:
1. The outer box or packaging of the drug must include a QR code that links to the electronic insert for that specific drug.
2. Before going paperless, pharmaceutical companies must notify all medical institutions and pharmacies (including those supplied via distributors) that have purchased the drug in the last six months, providing a detailed “implementation period plan.”
3. When necessary, pharmaceutical companies must provide paper package inserts upon request from medical institutions or pharmacies.
For further analysis of this Announcement, please feel free to contact our “Life Science” practice group.