Name: China Pharmaceuticals
Brand: TraceLink

Products

A scalable compliance data management and reporting infrastructure for China regulations

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Product overview

Comply with China’s serialization and reporting requirements

TraceLink China Pharmaceuticals enables pharmaceutical manufacturers to manage complex product, operational, and master data while isolating internal enterprise systems from the complexity and evolution of these emerging regulations. Manufacturers can also use the TraceLink solution to submit traceability reports that meet China’s drug traceability requirements.

With China Pharmaceuticals, you can:

Confidently meet China’s serialization and reporting requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from regional compliance demands

Industry challenges

New compliance requirements demand new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in China. These challenges include:

Complex product data management and reporting

China has defined a complex set of product master data, company master data, and production and distribution operational data for exported and imported products.

Complex product data management and reporting

Adherence to product encoding standards

China’s National Medical Products Agency (NMPA) has authorized two different product encoding standards: the global GS1 standard and the China-specific EDMC standard.

Adherence to product encoding standards

Navigation of China’s unique reporting infrastructure

Product identification, product master data, and manufacturing and operational data must be configured and reported upon into a three-tier traceability infrastructure defined by the Chinese government.

Navigation of China’s unique reporting infrastructure

Product benefits

Integrate with ready-to-go supply partners

Companies can leverage the extensive TraceLink network to speed partner integration and onboarding so they can begin exchanging key compliance information faster. The unique “Integrate-Once, Interoperate-with-Everyone™” capability enables manufacturers to connect with CMOs and 3PLs already on the platform through a single integration.

Product benefits

Support a wide range of business use cases

The flexibility of the TraceLink platform supports a wide range of business and operational use cases, and supply network configurations, for pharmaceutical manufacturers producing products distributed in the China market.

Product benefits

Meet new market requirements in a fraction of the time

Get extensive support for unique China data management and reporting requirements through the standardized, market-tested TraceLink Global Compliance Platform. Ensure the flexibility and agility needed for companies with multinational product portfolios and future growth plans.

Product benefits

Scale compliance across multiple markets and regulatory standards

The TraceLink Global Compliance Platform provides a future-proof foundation for companies that initially need to start with products encoded with the China EDMC/Ali-codes and then to migrate to GS1 standards in the future.

Product benefits

Insulate enterprise systems from individual market demands

The TraceLink China Pharmaceuticals solution enables manufacturers to manage and generate unique China serialized product identifiers, while also leveraging existing third-party enterprise solutions as part of a comprehensive, heterogeneous compliance approach.

Capabilities

TraceLink China Pharmaceuticals

This solution provides advanced compliance data management and reporting capabilities needed to meet the complex requirements of China's traceability regulations.

Manage workflows and data

Customize reports for specific use cases

Streamline report submission

Utilize flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements.

Support product encoding and reporting for medicines that use China eCode/EDMC/Ali-codes codes as well as GS1 standards.

Generate master data and traceability transaction reports for a variety of use cases.

Leverage the detection of reportable events by Serialized Operations Manager to gather the relevant serialization and compliance information required for reporting.

China Pharmaceuticals