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Global Compliance

China

The most proven solution for China compliance, with more than 1,107,907,024 serial numbers commissioned and more than 453,114,676 government reports created. Supporting customers in China since 2013, TraceLink kept pace with the 2013, 2014, and 2015 implementation phases and enabled companies to meet all of the market’s unique requirements, including the use of non-standard, China-specific identifiers; governmental involvement in serial number generation and report submissions; and significant complexity across product, production, and supply chain reporting.

Evolving Regulations

In March 2017, the government published a set of decrees highlighting some of the previous regulations as effectively null and void, and announced their intention to develop new drug quality requirements. Other recent developments include:

  • October 2017. Ministry of Commerce makes a joint announcement on the desire for a national standard across products, systems, and enterprises responsible for traceability.
  • December 2017. The GS1 China Traceability Workshop highlighted an interest in using GS1 standards (barcodes, product coding, and serialization), based on widespread industry feedback.
  • January 2018. GS1 Public Policy launches an end-to-end, stakeholder-managed China Pilot Workgroup to demonstrate GS1 standards, with full track and trace being discussed as a potential pilot objective. AliHeath was formally invited to participate as a target system.

Looking Forward

The government has identified 2020 as the target timeframe for the implementation of a standard traceability system, though it’s considered likely that regulations will be phased in by product class. It is also expected that the government will not own or mandate a single system, but may allow stakeholders to connect to multiple systems while maintaining governance access to all of them for monitoring purposes.

TraceLink will continue to monitor developments and when detailed regulatory requirements and specifications are published, will lead the way in helping companies navigate the new mandates. The core flexibility in TraceLink’s architecture — along with our long history of implementing and supporting China and other market’s specific requirements — will allow us to adapt quickly and help customers achieve compliance on time, and with the lowest possible cost and risk.

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