資產可視化：亞太製藥行業的跟蹤法規

本報告分析了亞太地區製藥行業跟蹤法規（資產可視化等）的趨勢，並提供以下信息。

報告的好處：

• 藥品供應商和分銷商可以製定戰略計劃，以應對序列化法規的變化。
• 提供對當前法規規模和範圍的看法。
• 我們提供有關未來監管修訂的建議。

分析大綱：

• 新興國家（中國、印度、馬來西亞）和發達國家（韓國、日本）市場的詳細分析
• 闡明區域趨勢和國家法規之間的差異
• 各層級序列化對比分析

主要問題的回答：

• 引入序列化規定的時間表是什麼？
• 可追溯性的關鍵數據標準和義務是什麼？
• 在國家法規中如何使用 GS1 等國際標準？

目標公司

目錄

• 執行摘要
• 主要用途
• 序列化數據表
• 全球監管環境
• 國內法規和國際標準
• 提案系統：概述
• 區域監管環境
• 合規性：強制性和自願性最佳做法
• 報告要求
• 負責跟蹤的供應商/3PL
• GDP（正確分配代碼）
• 處罰和罰款
• 實施規模和範圍
• 要跟蹤的項目
• 未來的修正
• 結論
• 定義和縮寫

Actionable Benefits:

• Strategic planning for pharmaceutical vendors and distributors for changes in serialization regulations.

• Gain insight into scale and scope of current regulations.

• Guidance into proposed future regulatory changes.

Research Highlights:

• Focus on emerging markets (China, India, and Malaysia) as well as developed markets (South Korea and Japan).

• Identifies variation between region-level trends and country-level regulations.

• Comparison and analysis of different levels of serialization.

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?

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.

Companies Mentioned:

Table of Contents

• Executive Summary
• Key Objectives
• Serialization Data Tables
• Global Regulatory Environment
• National Regulations and International Standards
• Summary of Proposed System
• Regional Regulatory Environment
• Compliance: Mandates versus Voluntary Best Practices
• Reporting Requirements
• Suppliers/Third Party Logistics Responsible for Track & Trace
• Good Distribution Practices
• Penalties and Fines
• Scale and Scope of Implementations
• Items Subject to Track & Trace
• Future Amendments Proposed
• Conclusion
• Definitions and Abbreviations