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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:
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
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.
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