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Will China Roll Out More Intermediate Deadlines Before 2022?

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As a consequence of the amended Drug Administration Law, there are new systems in place, new reports in place, data requirements serialization options. We have already seen an intermediate deadline of the 31st of December. The NMPA is acting very quickly. We expect them to establish other intermediate deadlines on the road towards full traceability in 2022.

This means that companies really need to act quickly, to analyze their business requirements, and to work with their affiliates to understand that what they're doing today will not be sufficient for what is required tomorrow.

TraceLink is helping its customers and people who have come to us interested in TraceLink to develop their China strategy. First, I'd like to mention our familiarity with the landscape because we already have a solution in place for the 2013, 2015 requirements. We have a pretty good idea of how the requirements will be interpreted and a little bit about the operational landscape in China.

We are working right now with customers to understand, because of the expanded scope of the Drug Administration Law, how their business operations will change, and consequently, how their reporting obligations will change.

Furthermore, TraceLink doesn't have all the answers, but we believe that by bringing heads together, by bringing industry leaders together, we can come up with the best answers and navigate the ambiguity that is quite present with China.
For example, we have a customer community that meets and discusses, for example, the interpretation of new requirements, how companies are approaching those requirements in terms of their operations, looking at the pros and cons of any one approach. Essentially, we have a brain trust of industry expertise that we can call on to help prepare others for their traceability journey in China.

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 how TraceLink can help companies be ready for intermediate deadlines as China implements its revamped traceability system.

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