TraceLink’s China Compliance application is designed to enable pharmaceutical manufacturers in managing compliance data and related reporting requirements for meeting China’s drug traceability requirements as defined in the 2019 Drug Administration Law and related National Medical Products Agency (NMPA) regulations such as Order 28.
China Compliance helps companies enable a high-performance, scalable compliance management and reporting infrastructure for China regulations while isolating internal enterprise systems from the complexity and evolution of these emerging regulations.
- Supports a wide range of business and operational use cases for marketing authorization holders and pharmaceutical manufacturers producing product for distribution to the China market
- Provides a common global platform for compliance reporting and compliance data management when used as part of TraceLink’s global track and trace compliance network
- Help future-proof companies who want or need to initially start with products encoded with the China EDMC/Ali-codes and desire to migrate to GS1 standards in the future
- Delivers flexibility in leveraging TraceLink serialization applications for China serialization management, or the use of existing third-party solutions which may be in place
- Leverages the extensive network of pre-existing integrations with CMOs and 3PLs to speed access to key compliance information
Capabilities and Features
China Compliance provides the intelligent compliance data management and reporting system needed for the complex master data and traceability transaction reports documented in China traceability regulations.
- Delivers flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements
- Generates master data and traceability transaction reports for a variety of use cases
- Enables flexible report submission either directly to government systems or through local partners
- Supports product encoding and reporting for medicines that use either China eCode/EDMC/Ali-codes codes or GS1 standards
- Leverages the detection of reportable events by Serialized Operations Manager to gather the relevant serialization and compliance information required for reporting
- Provides search, viewing, and audit trailing of submitted reports and system responses