A new survey conducted by TraceLink, a track and trace network, has revealed inconsistency in the life science industry’s readiness to comply with serialisation deadlines in the US and EU.
Rolled out in November 2017, the serialisation regulation requires the use of unique identifiers or serial numbers on all saleable units of products sold into the US.
Conducted in partnership with research firm Penn Schoen Berland, the study involved 660 respondents involved in the pharmaceutical supply chain.
The survey found that only one third of the respondents are ‘very prepared’ to comply with the deadlines, while 50% of the total 88 contract manufacturing organisation respondents said that they are ‘very ready’.
However, none of them have completed all the basic steps required for the trace and track deadlines.
Among those with EU Falsified Medicine Directive (FMD) requirements, a similar number of respondents believe they are ‘very ready’ for the deadlines.
The survey additionally found that after implementing the fundamental steps, only 50% of the EU FMD respondents are ‘truly ready’.
TraceLink president and CEO Shabbir Dahod said: “This year, serialisation becomes a true reality for many pharmaceutical companies. These survey results are startling.
“Despite goodwill efforts by industry and regulators to meet compliance on time, the industry is extremely behind in being ready for serialisation.
“In 2018, as we reach the final hours of serialisation in both the US and EU, the industry-wide lag in full serialisation implementations remains a concern and emphasises the criticality of trade partner connectivity within the supply chain.”
The survey further found that one quarter of wholesale distributors and 11% of hospital and pharmacy respondents are the ‘early movers’ in terms of their serialisation preparations and their ability to be ready prior to the DSCSA deadlines.