eLabeling More than Moving from Paper to Digital

Electronic or digital documents helped manage and disseminate clinical research data and information during the pandemic and are now being explored for potential use at the other end of this pipeline: the product safety and other information in the (paper) package insert. “Whether we are speaking of paper or electronic formats, this is the basic right, at the end of the day, for patients: to allow them that access and informed decision making about the use of their product,” suggests Aimad Torqui, executive director, Global Regulatory Policy, MSD (The Netherlands), and chair, Product Information Inter-Association Task Force (PI IATF). “It sounds very easy to move from one format to another. But there’s a lot of details to go through: How do we do submissions? How do we do approvals? Where is it published? How do people get access to it?”