20150225 ECA新闻：EU对US：新的跟踪和追溯要求是什么？

20150225 ECA新闻：EU对US：新的跟踪和追溯要求是什么？  

2015-02-27 20:10:55|  分类： ECA新闻

GMP News
25/02/2015

http://www.gmp-compliance.org/enews_04700_EU-vs-US-what-are-the-new-Track-and-Trace-Requirements.html

EU vs US: what are the new Track and Trace Requirements?

EU对US：新的跟踪和追溯要求是什么？

In 2011, the European Commission published Directive 2011/62/EC, the so called Falsified Medicines Directive (or FMD).One goal was the fight against counterfeit medicines through serialisation and verification. In 2014 the technical characteristics of these key ideas were defined, the unique identifier (UI), delivering the possibility of verification of the authenticity of single folding boxes. The unique identifier contains information on the:

在2011年，欧盟委员会公布了2011/62/EC指令，即所谓有药品防伪指令（或FMD）。其中一个目的即是通过序列编号和核实系统来防止伪药。在2014年，对这些关键思想的技术层面进行了界定，即唯一识别号（UI），可以核实折叠盒的真实性。唯一识别号包括以下信息：

• Manufacturer product code
• 生产商产品代码
• Serial Number
• 序列号
• National reimbursement number, if present
• 国家退税号，如有
• Batch Number
• 批号
• Expiry Date
• 有效期
  

The 2D barcode (data matrix) has been set as carrier of this unique identifier, a decision which did not come unexpected but rather late. The composition, format and carrier of this unique identifier will be fully harmonised across the EU.

二维码（数据矩阵）已被设定为该唯一识别码的载体，这个决定并不意外，但确实有点迟了。该唯一识别码的组成、格式和载体将在整个欧盟全面统一。

Medicine authenticity will be guaranteed by an end-to-end verification system supported by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. With the end-to-end scanning process of the data matrix, the authenticity of each packaging is automatically verified via a protected centralised database. If identical numbers are found or if a number cannot be found in the database, an alarm will be triggered immediately. The repository containing the unique identifiers will be set up and managed by the stakeholders. National competent authorities will be able to access and supervise the database.

药品真实性将由点对点核实系统来保证，由批发商通过基于风险的核实来支持。药品在被分发给患者前，将进行系统的核实。采用点对点数据矩阵扫描过程，每个包装的真实性将通过受保护的中央数据库进行自动验证。如果发现重复的编码，或在数据库中找不该编码，则会立即触发警报。相关方将建立并管理具有唯一识别码的信息库，国家药监当局将可以进入并监管该数据库。

As this new requirement will become active in 2018, it is time to start defining strategies for both technical implementation and change control strategy.

由于新的要求将于2018年生效，现在是时候开始制定技术实施策略和变更控制策略了。

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan, new requirements were defined in the USA which aim at improving the traceability of prescription drugs within the supply chain.

根据药品供应链安全法案（DSCSA）及相关的实施计划，在USA将界定新的要求，其目的是提高处方药在供应链中的可追溯性。

The DSCSA is focusing more on each step in the supply chain, tracking the different stages on the way to the pharmacist.

DSCSA更多关注在供应链的每个步骤，跟踪其经过的不同阶段直至药师。

On the FDA website, a graphic represents a summary of planned implementation timeframes for the Drug Supply Chain Security Act over a 10-year period. The major phases are:

• Lot-Level traceability and verification:
  Starting January 1 2015 for manufacturers, wholesalers and re-packagers; and July 1, 2015 for pharmacy (hospitals and retail): changes of ownership of a batch must be tracked.
• 批号层次追溯性和验证
  生产商、批发商和分包装商从2015年1月1日起，药房（医药和零售商）自2015年7月1日起：必须可以跟踪到批次的所有权变化
• Unique Serialization:
  From 2017 - 2019, single packages of drug products have to be marked with serialisation numbers and bar codes.
• 唯一序列编码
  自2017年至2019年，药品单个包装必须标识序列编码和条码
• Serialised Item-Level Traceability:
  From 2023, information must be provided to allow supply chain partners to trace the transaction history back to the initial manufacturer or re-packager.
• 序列项目层追溯性
  自2023年，必须提交信息允许供应链伙伴来跟踪转移历史，一直回溯至初始生产商或再包装商
  

The Drug Supply Chain Security Act Implementation Plan will be updated as appropriate.

适当时，药品供应链安全法案实施计划将进行更新。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015126103656387/

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