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TFDA announces series of format updating and digitization of drug labels and package inserts

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2023-01-05
  • Last Updated:2023-01-05
The label and package insert of a medicinal product are important mediums for delivering drug safety information to ensure that health care providers and the public use drugs correctly and pay attention to the occurrence of adverse reactions. They used to be printed and distributed to end users along with the medicinal products. In addition to the information updating requirements, the Taiwan Food and Drug Administration (TFDA) has issued a series of announcements on the format of labels and package inserts in the past five years. These changes are to make it easier for users to find the location of important information on labels and package inserts, and to understand the content more easily.
First, in March 2016, TFDA issued an announcement on the format of non-prescription drug label and package insert. The purpose of this policy is to ensure that contents are easy for customers to read and understand. At the same time, considering visually impaired customers and the elderly, it is required to print a QR code at a designated position on each over-the-counter drug package. The QR code includes information such as drug name, usage (indication), drug administration method, dosage form, drug appearance, consultation telephone number, etc. Customers can listen to drug information through the smart phone voice application system. By the end of 2019, all non-prescription drugs have completed the format updating.
Secondly, TFDA further announced the "Prescription Drug’s Package Insert Format" in the revision of "Regulations for the Registration of Medicinal Products" in September 2021. The published format of prescription drug package inserts shall be used for all the marketing authorization applications and post-approval change submissions starting on January 1, 2022. 
Besides the amendment of regulations, a label and package insert electronic system was developed and launched in May 2022. For each marketing authorization application or post approval change submission case, the pharmaceutical company is required to upload the label and package insert information to an electronic platform for review, verification, and approval. The public can directly inquire about the approved labels and package inserts through the Drug License Inquiry System on the TFDA website.
Easy access to information on package inserts is crucial for healthcare professionals and patients. The series of format updating requirements and digitization of drug labels and package inserts by TFDA will bring more convenience to users. The reforms will enhance public readability and comprehension. The practical efficiency for review of package insert revisions has also been improved through online evaluation. TFDA expects the public to make good use of this electronic system for querying information so as to elevate drug intelligence and keep in good health.