Pharmaceutical Serialization and Traceability: 2017 Trend Report



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The end of 2017 is peppered with serialization compliance deadlines for the pharma industry as it continues in the combat against counterfeit medicines. These regions include the likes of Canada, the US, Ukraine and the EU – with the Falsified Medicine Directive’s (FMD) deadline set for early 2019. After these deadlines, in order to trade in the markets in question, manufacturers must follow the new laws.

Despite the urgency, many medicine manufacturers are known to be behind schedule. In our 2016 research a number of participants admitted to not even thinking about serialization at all as of yet.

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As many as 400 contract manufacturing organizations (CMOs) will not be ready for the approaching US and EU serialization compliance deadlines


Supply chain
expert Tracelink predicts that as many as 400 contract manufacturing organizations (CMOs) will not be ready for the approaching US and EU serialization compliance deadlines. Tracelink estimates this equates to 50 per cent of the US’s and EU’s CMOs. This would leave many pharma firms without adequate support for serialization deadlines and, therefore, could spark a major shift in the CMO marketplace.

The late adopters are going to be critically reliant on excellence in project execution to get their programmes in place and delivered on time. A high level of optimism was implied in last year’s results in regards to time left to complete serialization projects. With deadlines looming, instead of being complacent the industry should utilize the time left to avoid any costly mistakes. 

The more prepared manufacturers are assessing the returns available from the legal requirements. More than 70 per cent of manufacturers, in a recent industry study commissioned by KPMG, appreciated that serialization requirements will have a positive impact on their business processes. 

With time running low, Pharma Logistics IQ tracks the state of the industry’s serialization projects. This year’s research report maps out and measures the changes in consensus as the industry advances closer to an entirely track-and-trace pharmaceutical environment.

Sections covered: 

  • Project Planning 

  • Implementation Progress 

  • Traceability In Operation 

  • Benefits Beyond Compliance

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