Gartner Research

Time for Action on Track and Trace in the Pharmaceutical Supply Chain

Published: 28 February 2013

ID: G00245707

Analyst(s): Todd Applebaum

Summary

Pharma manufacturers must begin implementing serialization and track and trace, or risk losing access to the U.S. market. Supply chain leaders at pharma manufacturers can use this research to shift from the wait-and-see approach of 2012 to building a compliant foundation.

Table Of Contents
  • Impacts

Analysis

Impacts and Recommendations

  • The 2015 and 2016 enforcement dates for California's pedigree law are pushing manufacturers around the world to begin investing now, or risk noncompliance and loss of access to the U.S. market
  • Continued regulatory uncertainty and varied requirements around the world are making it difficult for drug manufacturers to identify compliance requirements and make investments
    • Clarification of Compliance Requirements
    • Timeline for Enforcement
    • Federal Pre-emption
    • Global Requirements
  • Three likely solution models have emerged for interoperable track and trace across the pharmaceutical value chain, and they continue to evolve, placing manufacturers' early investments at risk
    • Document-Centric E-Pedigree
    • PoD Authentication
    • Network-Centric (Full) Track and Trace

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