This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada, and Taiwan. These regulations are initiated by the respective governments and/or health authorities of those countries and the EU in collaboration with key stakeholders, including patients, healthcare professionals (HCPs), pharmaceutical companies, and environmental and regulatory agencies. Each country/region uses different legal definitions and terminologies and is designated as either Tier 1 or Tier 2, depending on the maturity of the regulation and operational requirements. The article also considers the benefits and value associated with transitioning from paper to e-labeling for respective stakeholders.
