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[Resource Center](/resources/resource-center) # Will My Current China Reports Work with the New Traceability Systems? ![banner-image](https://www.tracelink.com/sites/default/files/_global-asset/images/insights/china-insights-thumbnail_v02.png) - [Download PDF](/node/15201/pdf) - [Share](#) - [ LinkedIn ](https://www.linkedin.com/shareArticle?mini=true&url=https://www.tracelink.com/resources/resource-center/will-my-current-china-reports-work-with-the-new-traceability-systems&title=Will My Current China Reports Work with the New Traceability Systems?&summary=Learn how China’s amended Drug Administration Law expands the scope of NMPA reporting requirements and impacts your company’s serialization strategy.&source=TraceLink "LinkedIn") - [ Facebook ](https://www.facebook.com/share.php?u=https://www.tracelink.com/resources/resource-center/will-my-current-china-reports-work-with-the-new-traceability-systems&t=Will My Current China Reports Work with the New Traceability Systems? "Facebook") - [ Mail ](mailto:?subject=Will My Current China Reports Work with the New Traceability Systems?+|+TraceLink&body=https://www.tracelink.com/resources/resource-center/will-my-current-china-reports-work-with-the-new-traceability-systems "Mail") - [ Twitter ](https://twitter.com/intent/tweet?text=Will My Current China Reports Work with the New Traceability Systems? https://www.tracelink.com/resources/resource-center/will-my-current-china-reports-work-with-the-new-traceability-systems&via=TraceLink "Twitter") #### Table of contents ![](https://play.vidyard.com/dxCxqDsaV6hvADWmieP6xe.jpg) ### Read the transcription You may know there was a traceability regulation in China between 2013 and 2015 that required serialization and some reporting. The new law brings in further options for that serialization, and it greatly expands the scope of reporting and the data that's required to do that reporting. In looking at the new China reporting requirements, TraceLink did an analysis of looking at, say, a manufacturer who is importing product into China, and we took a look at how fit for purpose would the data be in the reports for the previous regime. How could that data be used to satisfy the requirements under that scenario? In that scenario alone, we found that there were 35 fields that were not in the old reports that are in the new reports. That not only brings to light the increased data requirement, it then will cause businesses to think, "Where are we going to source that data from, and how can we report that data in a consistent and, let's say, a seamless manner in the future?" Companies must not assume that compliance with the old regime will bring them into compliance with the new regime. In fact, we've seen that reports have changed, the data has changed, the serialization options have changed. The old reports simply do not meet the requirements of the new traceability systems. This is requiring quite a revamp, I should say, of the framework that companies need to prepare. I would encourage local affiliates and their global counterparts to investigate the new reports that they will be accountable for in detail, in terms of events, in terms of data, in terms of sequencing operations, in order to ensure that they are prepared for this new traceability system and traceability reports. From our own analysis, there is a significant gap between just even the data required between the old reports. With the new system, there's likely to be new schema and other requirements as well at a technical level. The new Drug Administration Law really does cover many facets. It's an entire revamp of the supply chain in China in terms of traceability. China’s amended Drug Administration Law introduces new systems, new data and reporting requirements, and new serialization options—and new urgency for companies doing business in China. In this 2-minute video, TraceLink’s Director of Industry Marketing and Community, Allan Bowyer, discusses the expanded scope of China’s reporting requirements under the new law, and the decisions companies need to make to prepare. [Video](/category/video)[China Pharmaceuticals](/category/china-pharmaceuticals)[Global Track & Trace](/category/global-compliance)[Regulatory/Compliance](/category/regulatory-compliance)[China](/region-type/china) #### Table of contents Learn more about TraceLink's China compliance solution. Contact us Learn more about TraceLink's China compliance solution. 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/china-ecode-or-gs1-encoding-weighing-the-benefits-and-risks) ##### China eCode or GS1 Encoding? Weighing the Benefits and Risks China eCode or GS1 Encoding: Which one is right for you? Watch this short webinar excerpt to understand key considerations for your China product strategy. [View More](/resources/resource-center/china-ecode-or-gs1-encoding-weighing-the-benefits-and-risks) [ ![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_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) [ ![flbposter_ferrer-thumbnail.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/flbposter_ferrer-thumbnail.png.webp?itok=kQasJEB-) ](/resources/resource-center/case-study-ferrer-building-a-master-data-strategy-for-eu-fmd) ##### Case Study: Ferrer | Building a Master Data Strategy for EU FMD Learn how Ferrer worked with TraceLink to manage its master data for EU FMD compliance. [View More](/resources/resource-center/case-study-ferrer-building-a-master-data-strategy-for-eu-fmd) [ ![eu-fms-video-clip-2.jpg](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/eu-fms-video-clip-2.jpg.webp?itok=hoJjb9zP) ](/resources/resource-center/cmo-line-upgrades-who-will-pay) ##### CMO Line Upgrades: Who Will Pay? Pharma companies and CMOs must work together closely to be ready for serialization, yet there is no established commercial model. Learn about the dynamics. [View More](/resources/resource-center/cmo-line-upgrades-who-will-pay) [ ![eu-flag-yellow-600x338.png](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/eu-flag-yellow-600x338.png.webp?itok=t99vPPEm) ](/resources/resource-center/serialization-onboarding-partnerships-the-hub-under-eu-fmd) ##### Serialization, Onboarding Partnerships & the Hub under EU FMD Learn from use cases that explore hub connectivity, onboarding & implementation timelines to meet compliance by February 2019. [View More](/resources/resource-center/serialization-onboarding-partnerships-the-hub-under-eu-fmd)