Asset Visibility: Pharma Industry Track and Trace Regulations in North America

Price: Starting at USD 4,500
Publish Date: 11 Feb 2022
Code: PT-2569
Research Type: Presentation
Asset Visibility: Pharma Industry Track and Trace Regulations in North America
Actionable Benefits

Actionable Benefits

  • Strategic planning for pharmaceutical vendors and distributors for changes in serialization regulations.
  • Gain insight into scale and scope of regulations.
  • Guidance into proposed future regulatory changes.
Critical Questions Answered

Critical Questions Answered

  • What is the timeline for implementation of serialization regulations?
  • What are the key data standards and mandates for traceability?
  • How are international standards like GS1 leveraged in national regulations?
Research Highlights

Research Highlights

  • Regional focus on North America (US and Canada).
  • Identifies variation between North American regulations and other regions.
  • Comparison and analysis of different levels of traceability.
Who Should Read This?

Who Should Read This?

  • Strategy planners and advisors within the pharmaceutical and supporting logistics industry.
  • Managers aiming to identify regulatory requirements of their operations.
  • For serialization software and hardware providers to assess regulatory impact on the pharmaceutical market.

Table of Contents

Executive Summary

Global Regulatory Environment

Regional Regulatory Environment

Key Objectives

National Regulations and International Standards

Summary of Proposed System

Compliance: Mandates versus Voluntary Best Practices 

Reporting Requirements

Suppliers and 3PLs Responsible for Track & Trace (T&T)

Good Distribution Practices

Legal Enforcement

Scale and Scope of Implementations

Items Subject to Track & Trace (T&T)

Future Amendments Proposed

Regulatory Timeline

Serialization Data Tables

Definitions and Abbreviations