![banner-image](https://www.tracelink.com/sites/default/files/2024-02/China%20Pharmaceuticals.png) Products ## Breadcrumb 1. [Home](/) 2. [Country Compliance](/products/product-orchestration/country-compliance) # China Pharmaceuticals A scalable compliance data management and reporting infrastructure for China regulations blue 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. Contact Us Contact Us document.addEventListener("DOMContentLoaded", function() { // Delay the execution by 2 seconds (2000 milliseconds) setTimeout(function() { (function() { 'use strict'; // Load Marketo form MktoForms2.loadForm("//go.tracelink.com", "776-BAW-230", 2259); })(); // Wait until the Marketo form is loaded MktoForms2.whenReady(function(form) { var formElement = document.getElementById('mktoForm_2259'); if (!formElement) { console.error("Form with id 'mktoForm_2259' not found."); return; } var formLocation = formElement.querySelector("input[name=formLocation]"); // Get the current URL and set the formLocation field if (formLocation) { var currentURL = window.location.href; formLocation.value = currentURL; } // Add onSuccess handler form.onSuccess(function(values, followUpUrl) { var formElem = form.getFormElem()[0]; if (formElem) { formElem.style.display = 'none'; } else { console.warn("Form element could not be found to hide it."); } var confirmMessage = document.getElementById('confirmform'); if (confirmMessage) { confirmMessage.style.display = 'block'; } else { console.warn("Confirmation message with id 'confirmform' not found."); } return false; // Prevent the form from submitting normally }); }); }, 2000); // Delay for 2 seconds }); **Thank you for contacting us; we’ll be in touch shortly.** ##### 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 ## How TraceLink China Pharmaceuticals drives efficiency ## Integrate with ready-to-go supply partners ## Support a wide range of business use cases ## Meet new market requirements in a fraction of the time ## Scale compliance across multiple markets and regulatory standards ## Insulate enterprise systems from individual market demands ![china compliance](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/china%20compliance%203.png.webp?itok=h40YLRpg) 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. ![For Internal 9](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/For%20Internal%209.png.webp?itok=9DOmXrE6) 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. ![china compliance](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/china%20compliance%201.png.webp?itok=xmxTVffI) 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. ![MINT](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/MINT%202.png.webp?itok=OGxgsPOr) 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. ![Digital documents](https://www.tracelink.com/sites/default/files/styles/vertical_drawer_desktop_600px_x_336px_/public/2024-02/Digital%20documents%205.png.webp?itok=WBWx39_b) 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 ![data](https://www.tracelink.com/sites/default/files/styles/tabs_component_desktop_574_x_380_/public/2024-02/For%20Internal%2063.png.webp?itok=249GsLtz) 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. Read More Read Less ![serial](https://www.tracelink.com/sites/default/files/styles/tabs_component_desktop_574_x_380_/public/2024-02/For%20Internal%2088_0.png.webp?itok=L4m3a-rQ) 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. Read More Read Less ![messages](https://www.tracelink.com/sites/default/files/styles/tabs_component_desktop_574_x_380_/public/2024-02/For%20Internal%2028.png.webp?itok=82Ay2iLL) Submit reports either directly to government systems or through local partners. Search, view, and trail submitted reports and system responses for audits. Read More Read Less ### Explore related products [ See all products ](/products/product-explorer) [ Serialization ](/category/serialization) [ Serial Number Manager ](/products/product-orchestration/serialization/serial-number-manager) [ Serialization ](/category/serialization) [ Serial Number Exchange ](/category/serial-number-exchange) [ Serialization ](/category/serialization) [ Serialized Operations Manager ](/products/product-orchestration/serialization/serialized-operations-manager) [ OPUS Digital Network Platform ](/solution-suite/opus-platform-enabling-products) [ Master Data Exchange ](/products/network-platform-enabling-applications/master-data-exchange) ### Related resources [ See more resources ](/resources/resource-center) ![](/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v02.png.webp?itok=mptgY_Kv) ##### EDMC or GS1? 3 Keys to Choosing Your China Traceability System Provider See what companies should consider when choosing between GS1 and EDMS encoding in China, and how… [Get Details](/resources/resource-center/edmc-or-gs1-3-keys-to-choosing-your-china-traceability-system-provider "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v01.png.webp?itok=CbJmpNOr) ##### China Reporting and Compliance Systems: Key Considerations What makes China compliance so challenging? Watch this brief overview of China’s 3-tier reporting… [Get Details](/resources/resource-center/china-reporting-and-compliance-systems-key-considerations "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v02.png.webp?itok=mptgY_Kv) ##### China Progress Report: Industry Driving Discussions on Encoding and System… There are new signs that the implementation of China’s comprehensive track and trace system is… [Get Details](/resources/resource-center/china-progress-report-industry-discussions-on-encoding-and-system-capabilities "Get Details") COUNTRIES ### Compliance around the globe Explore specific country compliance solutions offered to the TraceLink network. [ See all countries ](/products/product-orchestration/country-compliance) ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/China%20Pharmaceuticals.png.webp?itok=gEg8xUbK) ##### South Korea Pharmaceuticals Advanced data management and reporting solution for compliance with South Korea pharmaceutical… [Get Details](/products/product-orchestration/country-compliance/south-korea-compliance "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/Bahrain%20Compliance_1.png.webp?itok=Btd2a7e0) ##### Russia Pharmaceuticals TraceLink Russia Pharmaceuticals application enables pharmaceutical manufacturers to manage… [Get Details](/products/product-orchestration/country-compliance/russia-compliance "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/India%20Pharmaceuticals_0.png.webp?itok=S6ZCu6FV) ##### Russia Biologically Active Food Supplements (BAFS) Advanced compliance data management and reporting solutions for biologically active food… [Get Details](/products/product-orchestration/russia-biologically-active-food-supplements-bafs "Get Details") ![](/sites/default/files/styles/resize_image_style_640_480/public/2024-02/Indonesia%20Compliance_0.png.webp?itok=ye9GFPZo) ##### Indonesia Pharmaceuticals Advanced compliance data management and reporting solution for Indonesia pharmaceutical… [Get Details](/products/product-orchestration/country-compliance/indonesia-compliance "Get Details") ![Country Compliance for Pharmaceuticals](https://www.tracelink.com/sites/default/files/styles/recovery_banner_desktop_1224_x_386/public/2024-02/Country%20Compliance_2.png.webp?itok=dY4teYr8) ### Join the China special interest group See how other companies are approaching new traceability regulations in China, being phased in after it overhauled its serialization laws and traceability system infrastructure. [ Join the community ](/resources/community/china-sig)