资产可视化：亚太製药行业的跟踪法规

本报告分析了亚太地区製药行业跟踪法规（资产可视化等）的趋势，并提供以下信息。

报告的好处：

• 药品供应商和分销商可以製定战略计划，以应对序列化法规的变化。
• 提供对当前法规规模和范围的看法。
• 我们提供有关未来监管修订的建议。

分析大纲：

• 新兴国家（中国、印度、马来西亚）和发达国家（韩国、日本）市场的详细分析
• 阐明区域趋势和国家法规之间的差异
• 各层级序列化对比分析

主要问题的回答：

• 引入序列化规定的时间表是什么？
• 可追溯性的关键数据标准和义务是什么？
• 在国家法规中如何使用 GS1 等国际标准？

目标公司

目录

• 执行摘要
• 主要用途
• 序列化数据表
• 全球监管环境
• 国内法规和国际标准
• 提案系统：概述
• 区域监管环境
• 合规性：强制性和自愿性最佳做法
• 报告要求
• 负责跟踪的供应商/3PL
• GDP（正确分配代码）
• 处罚和罚款
• 实施规模和范围
• 要跟踪的项目
• 未来的修正
• 结论
• 定义和缩写

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