2016 Serialisation and Traceability Industry Trend Report

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The war against counterfeit pharmaceuticals in the supply chain is well underway, with more than 40 markets – those of which including the EU, US, South Korea, Brazil and China, deploying pharmaceutical track and trace laws. According to industry specialist Tracelink, by the end of 2018 more than 75% of the globe’s prescription medications are expected to be protected by legislation.

Our research last year showed that even through pharmaceutical firms seemed to be experiencing growing pains as they evolved to new requirements, the tall task of serialisation is one that appears to be within reach for most via apt planning and testing.

However, minor industry confusion remained in certain corners of the market, aggravated by the lack of cohesion between countries’ varying legislative approaches. One survey member highlighted the frustration caused by ‘moving targets’ and similarly a level of research participants predicted that the publishing of the EU Delegated Acts would be delayed once again. Experts predicted that once the acts were published, they would help ‘tighten up loop-holes’ and be instrumental in the market’s maturation towards global harmonization. 

2016 witnessed the publishing of EU Falsified Medicines Directive (FMD). The FMD regulations declare that the following specifications must be on every medicines pack: a unique identifier in the form of a two dimensional data barcode and the verification of safety features which include the integrity of the anti tampering device. A lead time of just over two years has been set, leaving some questioning whether this will be enough time for the entire market to evolve to the requirements. Industry players are experiencing another time pressure on protecting their current market access as the next level of the US DSCSA is due to go live next year.

This year’s research report maps out and measures the changes in consensus as the industry advances closer to an entirely track and traced pharmaceutical environment.