Gartner Research

An Assessment of Global Regulations Across the Healthcare Value Chain Requiring Track and Trace With Serialization

Published: 05 February 2020

ID: G00418228

Analyst(s): Andrew Stevens


Supply chain leaders across the life science industry and healthcare value chain can use this assessment of the current and upcoming global regulatory landscape to fully comprehend the requirements and modes of execution for adopting track and trace with serialization.

Table Of Contents


  • Definitions of Counterfeit and Fake Medicines or Products
  • Market Dynamics Behind Counterfeit and/or Fake Pharmaceuticals, and the Business Need for Track and Trace With Serialization
  • Data and Coding Building Blocks That Shape Global Regulations
    • Batch Coding
    • Serialization (and Serial Numbers)
    • Track and Trace
    • Product Authentication and Verification
  • Decision Making and Challenges for Deployments of Track and Trace With Serialization as Part of IT Infrastructure for Aligned Compliance Mandates
  • The Current Global Status of the Regulatory Outlook for Track-and-Trace With Serialization Regulations
  • Prioritize These Seven Countries and/or Regions for Phased Compliance Deadlines Across 2020 and Into 2021 for Batch Coding, and Track-and-Trace With Serialization Compliance Mandates
  • Recommendations

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