Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.
In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.” It is to help sponsors include dose banding information in drug labeling for ready-to-use containers in New Drug Applications (NDAs), Biologics License Applications (BLAs), or supplements to those applications.
In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity and Strength - Content and Format of Labeling for Human Non-prescription Drug Products.” The draft guidance aims to enhance the consistency of labeling for Over-the-Counter (OTC) drugs. It addresses the statement of identity and drug strength for OTC products.
With digitalization taking up the world, some might say that paper leaflets are an outdated approach. Paper leaflet copies can become outdated whenever new safety or effectiveness information is released, making it challenging for manufacturers to update their leaflets.
Drug labeling and package leaflets play an important role for both patients and healthcare professionals in the safe and efficient use of the medication. Hence, the approval of the labeling content, Patient Information Leaflet (PIL), and Summary of Product Characteristics (SPC) are integral components of the marketing authorization process.