Will My Current China Reports Work with the New Traceability Systems?

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.