More than one third (40%) of pharmaceutical industry professionals are not confident that they will meet serialisation deadlines in the US and Europe, according to new industry research.
As FDA has announced plans to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US to November 2018, the research, conducted by serialisation system provider SEA Vision and life science technology specialist Zenith Technologies, gives further evidence for the need for additional time both in the US and Europe.
Just 18% of those that took part in the survey are “extremely confident” that they will meet impending track and trace deadlines, including the US DSCSA and the European Falsified Medicines Directive (FMD).
Highlighting a major cause of the lack of preparedness, 40% of industry professionals admit that they are not clear what the global requirements for serialisation are.
Despite the lack of understanding, the majority (38%) of companies will rely on an in-house team to handle the entire implementation. One third will use an implementation partner and 20% will rely on their software and hardware providers for the required support and expertise.
Commenting on the research findings, Carlos Machado, Serialisation Director at SEA Vision US, said: “Clearly, the industry is going through a challenging period and there is nervousness around whether the supply chain will be ready for compliance deadlines in the US and Europe.”
“The delay of the active enforcement of the DSCSA should not be viewed as a reason to be complacent, but instead the chance for small and mid-sized manufacturers that are behind in their serialisation journey to get their preparations back on track.”
“Just 43% of those companies surveyed are already supplying serialised products to other markets where regulations are in place, so for many, the DSCSA and the FMD are steps into the unknown. As a result, we believe that reliance on implementation partners will increase and this brings about new challenges as demand may surpass capacity as the deadlines draw closer.”
In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialisation across drug manufacturing sites.
The collaboration brings together Italian-based SEA Vision’s serialisation system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.
For more information on how to overcome the challenges of serialisation and steps to take for late starters, a free eBook can be downloaded at http://www.seavision.it/category/e-books/