International – Global Electronic Labeling Initiatives: Updates from Japan, Canada, Europe, US, and Asia

Electronic labeling is the focus of many ongoing initiatives across regions. E-labeling can deliver the latest labeling information immediately and in an efficient and customer-friendly way for patient safety. Also, e-labeling is driven by the acceleration of digital disruption and must consider patient-centricity.

DIA’s recent Global Labeling Conference 2020 opened with industry and regulatory experts discussing the current landscape of electronic labeling initiatives in Japan, Canada, Europe, Belgium and Luxembourg, US, and Asia.

Key Takeaways

  • Japan’s Pharmaceuticals and Medical Devices Act was amended to introduce e-labeling officially, replacing paper labeling and adding a necessary scheme that allows all healthcare professional access the up-to-date labeling information.
  • Health Canada is taking steps to transition the product monograph to a new structured format based on Extensible Markup Language (XML), Health Level 7 (HL7) standards, and controlled vocabularies.
  • Together with other relevant stakeholders, European regulators have established high level key principles that will guide future work in establishing, for example, common electronic standards, processes, and governance that all need to benefit public health.
  • The US Food and Drug Administration (FDA) has long sought to leverage digital platforms for prescription drug labeling intended for physicians and pharmacists, allowing for distribution of prescribing information in a timely manner…