Protect Patients Enable Health

China Serialization and Reporting

China's pharmaceutical serialization and government reporting regulations are phasing in. Today, drugs on the 2009/2012 National Essential Drugs List need to be serialized. By Dec. 2015, all drugs for China need serialization and reporting.

For guaranteed China compliance and secure access to China markets, you need:

  • An integrated serialization and reporting solution meeting unique China regulations
  • A commercially proven solution used by multiple top-20 pharma today
  • A China compliance approach harmonized with your global track and trace needs
  • A cloud-based network platform linking all external supply and distribution partners
  • A solution partner with deep China regulatory knowledge and commercial expertise

Solution Vision

TraceLink delivers with full compliance for unique China regulations while supporting your unique production, packaging and distribution operations on a standardized global track and trace platform:

  • Importation and maintenance of unique China EDMC codes generated through the China CFDA system
  • Integrated serialization management, aggregation control and serial number replenishment for all product types and packaging configurations
  • Serial number exchange with internal packaging sites and external partners regardless of line system
  • Complete compliance event capture and management from commissioning through shipment with an integrated EPCIS repository
  • Automated, fully compliant China report generation supporting unique China file requirements
  • Capture and use of required master data developed during China product registration
  • Full exception management

Why It's Important

Watch our China webinars on the unique China regulatory and business requirements to see why a China-specific, globally harmonized compliance solution is crucial to ensure efficient, secure China compliance.

Hear Pfizer and TraceLink describe the pharmaceutical manufacturer's perspective on the business strategy, IT architecture and supply network deployment requirements for harmonized global China compliance.

TraceLink Solutions

A single connection to the Life Sciences Cloud delivers an end-to-end solution from serial number generation through compliant government reporting for pharmaceutical companies, CMO/CPOs and more:

  • Serial Number Manager: Capture and manage gov't generated China EDMC codes and create full aggregation hierarchies for all products
  • Serial Number Exchange: Exchange serial number requests and serialization events between packaging lines, locations and serial number management systems in a central, coordinated fashion
  • Serialized Operations Manager: Centrally manage serialized inventory operations in plants/warehouses (internal, CMO/CPO, 3PL), maintain aggregation relationships and trigger compliance activities
  • China Government Reporting: Generate fully compliant China reports, supporting unique China reporting rules as required for all China events, out of the box
  • ServiceLink: Publish serialization and reporting services to external partners in the China manufacturing and distribution chain and centrally manage user access and subscriber permissions

Business Impact

  • Reduced risk in meeting the unique China serialization and reporting regulations
  • Efficient manufacturing, packaging and distribution to meet fast growing China market demand
  • Improved agility and control by integrating China compliance activities into a global track and trace management

Awards and Recognition

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