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[Resource Center](/resources/resource-center) # New China Packaging Specs Point to Patient-Level Data Visibility ![banner-image](https://www.tracelink.com/sites/default/files/_global-asset/images/events/thumbnails/china-compliance-thumbnail.png) - [Download PDF](/node/20796/pdf) - [Share](#) - [ LinkedIn ](https://www.linkedin.com/shareArticle?mini=true&url=https://www.tracelink.com/resources/resource-center/new-china-packaging-specs-point-patient-level-data-visibility&title=New China Packaging Specs Point to Patient-Level Data Visibility&summary=Learn how China’s new standards could impact how your company prepares and prints product data for the China market.&source=TraceLink "LinkedIn") - [ Facebook ](https://www.facebook.com/share.php?u=https://www.tracelink.com/resources/resource-center/new-china-packaging-specs-point-patient-level-data-visibility&t=New China Packaging Specs Point to Patient-Level Data Visibility "Facebook") - [ Mail ](mailto:?subject=New China Packaging Specs Point to Patient-Level Data Visibility+|+TraceLink&body=https://www.tracelink.com/resources/resource-center/new-china-packaging-specs-point-patient-level-data-visibility "Mail") - [ Twitter ](https://twitter.com/intent/tweet?text=New China Packaging Specs Point to Patient-Level Data Visibility https://www.tracelink.com/resources/resource-center/new-china-packaging-specs-point-patient-level-data-visibility&via=TraceLink "Twitter") #### Table of contents On June 21, China’s National Medical Products Administration (NMPA) published a “call for comments” on two new standards for drug traceability that could have a significant impact on how manufacturers prepare their products—and data about those products—for the China market. Key takeaways include: - NMPA has ”visualized” how data about domestic and imported products would be displayed as a result of a patient query. - In addition to the EDMC or GS1-standard product identifier, the label itself must be clearly identified as the “Drug Traceability Code” to distinguish it from other barcodes. - The printing specifications include provisions for both linear barcodes and GS1-compliant 2D data matrix barcodes. The new standards are in addition to the 10 standards that have already been published since 2019. NMPA is requesting feedback by July 20, 2021. ### NMPA Printing Specification of the Drug Traceability Code The Drug Traceability Code (DTC) is defined in the 2019 standard, “Guidelines for the Construction of the Drug Information Traceability System,” as a unique sequence of numbers, letters and/or symbols that identify each level of a drug’s packaged unit. The June 2021 draft specifications provide additional requirements on the quality and appearance of the DTC: - Labels must be readable by humans as well as by scanning equipment. - Labels must have a clear image of the DTC and appropriate contrast with background. - Labels must include the words “Drug Traceability Code.” - Labels must be easily locatable on the package. - Labels must be readable either from left-to-right or top-to-bottom. ![China NMPA packaging standards for linear and data matrix barcodes](https://www.tracelink.com/sites/default/files/_global-asset/images/insights/China-barcode-packaging-inline.png)In addition to specifications for linear and data matrix barcodes, the June 21 draft also includes guidance on application and placement of the DTC, including provisions for drug packages fewer than 10 square centimeters; distinct requirements for 1-dimensional linear barcodes and 2-dimensional data matrix barcodes; and the correct application of multiple labels bearing the DTC on large packages. ### NMPA Drug Traceability Code Consumer Query Results This new specification complements the existing standard, “Basic Data Set for Drug Traceability Consumer Inquiry,” and the information a patient would see when requesting a medicine’s traceability information from the NMPA’s Drug Information Traceability System. This new standard reinforces the significant “data gap” between China’s 2015 regulations and the 2019 regulations currently being implemented by the NMPA. For companies importing drugs into the China market, the data set for consumer queries is extensive and appears to be a mix of master data, product data, and government registration and reporting data. Note that this is an unofficial translation of the original Mandarin document: - Drug traceability code - Drug status - National drug identifier code - Generic name - English name of the drug - Chinese name of the imported drug - Drug standard code - Dosage form - Formulation specifications - Packing specification - Packaging conversion ratio - Drug expiration date - Drug expiration unit - Drug approval number - Drug approval number expiration date - Registration number of the imported drug - Expiration date of the registration number of the imported drug - Imported drug batch number - Expiration date of the Imported drug batch number - Drug registration classification - Drug expiry date deadline - Batch number - Drug usage department - Health agency code - National standard drug identification - Special drug management classification - Prescription drug identification - Name of the holder of overseas drug marketing authorization (English) - Unified social credit code (holder of overseas drug marketing authorization) - Name of the holder of domestic drug marketing authorization (English) - Unified social credit code (holder of domestic drug marketing authorization) - Name of overseas drug manufacturer (English) - Unified social credit code (overseas drug manufacturer) - Name of repackager - Unified social credit code (repackager) - Name of importer - Unified social credit code (importer) - Drug manufacturing date - Unified social credit code of the Drug usage department - Name of drug retailer - Unified social credit code (retailer) While the document provides visualizations for domestically produced and imported medicines and specifies that it is to be free of any adware, it does not describe the process of submitting a query or indicate if a web-based platform or API links might be used to respond to a barcode scan. ### Is your company prepared for the new NMPA traceability requirements? As the NMPA continues to release more detailed specifications on its 3-tier traceability system, companies can expect new challenges as they adapt their China packaging and serialization solutions to meet the new, more complex requirements. TraceLink customers can stay ahead of the latest developments by joining one of TraceLink’s China Special Interest Groups. To register, visit the [TraceLink communication preference center](https://go.tracelink.com/tracelink-communication-center "Link to TraceLink Communication Preference Center"): - Select “Join the TraceLink Community” checkbox to display Community options. - Select the “China” Community. - A Mandarin-speaking group is also available: Select “Greater China Region (Mandarin).” - Scroll to the bottom of the page and select the “Update Communication Preference” box to submit your request. [Blog](/category/blog)[China Pharmaceuticals](/category/china-pharmaceuticals)[Global Track & Trace](/category/global-compliance)[Manufacturing](/category/manufacturing)[China](/region-type/china) #### Table of contents Contact Us Learn more about TraceLink China compliance solutions 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.** ##### More China Compliance Resources [ ![china-insights-thumbnail_v01.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v01.png.webp?itok=CbJmpNOr) ](/resources/resource-center/must-know-china-track-and-trace-compliance-terms-for-the-pharmaceutical-supply-chain) ##### Must-Know China Track and Trace Compliance Terms for the Pharmaceutical Supply Chain The 2019 China Drug Administration Law introduced track and trace terms and agencies that you need to understand for your China compliance strategy. [View More](/resources/resource-center/must-know-china-track-and-trace-compliance-terms-for-the-pharmaceutical-supply-chain) [ ![china-insights-thumbnail_v01.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v01.png.webp?itok=CbJmpNOr) ](/resources/resource-center/china-reporting-and-compliance-systems-key-considerations) ##### China Reporting and Compliance Systems: Key Considerations What makes China compliance so challenging? Watch this brief overview of China’s 3-tier reporting system to help guide your China serialization strategy. [View More](/resources/resource-center/china-reporting-and-compliance-systems-key-considerations) [ ![china-insights-thumbnail_v01.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v01.png.webp?itok=CbJmpNOr) ](/resources/resource-center/china-qa-preparing-for-new-reporting-data-and-encoding-requirements) ##### China Q&A: Preparing for New Reporting, Data, and Encoding Requirements Learn how China’s National Medical Products Administration (NMPA) new reporting requirements and serialization options will affect pharmaceutical companies. [View More](/resources/resource-center/china-qa-preparing-for-new-reporting-data-and-encoding-requirements) [ ![china-insights-thumbnail_v02.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v02.png.webp?itok=mptgY_Kv) ](/resources/resource-center/are-your-products-china-ready-three-key-decisions-for-multinational-pharma-companies) ##### Are Your Products China Ready? Three Key Decisions for Multinational Pharma Companies China's drug administration law and serialization framework for medicines could affect your China product packaging strategy. Learn how today. [View More](/resources/resource-center/are-your-products-china-ready-three-key-decisions-for-multinational-pharma-companies) [ ![china-insights-thumbnail_v02.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v02.png.webp?itok=mptgY_Kv) ](/resources/resource-center/will-my-current-china-reports-work-with-the-new-traceability-systems) ##### Will My Current China Reports Work with the New Traceability Systems? Learn how China’s amended Drug Administration Law expands the scope of NMPA reporting requirements and impacts your company’s serialization strategy. [View More](/resources/resource-center/will-my-current-china-reports-work-with-the-new-traceability-systems) [ ![china-insights-thumbnail_v02.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/china-insights-thumbnail_v02.png.webp?itok=mptgY_Kv) ](/resources/resource-center/edmc-or-gs1-3-keys-to-choosing-your-china-traceability-system-provider) ##### 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 that affects their choice of traceability system provider. [View More](/resources/resource-center/edmc-or-gs1-3-keys-to-choosing-your-china-traceability-system-provider)