According to research recently performed by SEA Vision and Zenith Technologies, 40% of pharmaceutical industry professionals are lacking confidence in their ability to meet the upcoming US and European serialisation deadlines.
Lacking confidence
Only 18% of survey respondents indicated that they are ‘extremely confident’ that they will meet impending track and trace deadlines, including the US DSCSA and the European Falsified Medicines Directive (FMD).
Additionally, a large proportion of participants (40%) admitted that they are not clear on what the global requirements for serialisation are. However, despite this lack of understanding, implementation procedures were revealed as follows: 38% of companies will rely on an in-house team; 33% will use a partner; and 20% will rely on software and hardware providers.
“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,” explained Carlos Machado, serialisation director at SEA Vision US. “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.”
SEA Vision and Zenith Technologies formed a global partnership last year to support pharmaceutical companies with the challenge of installing and integrating serialisation across drug manufacturing sites.