Serialisation has been an industry hot topic for some time now, with the counterfeit medicines market costing the pharmaceutical industry billions every year and seriously compromising patient safety. However, despite new track and trace regulations being introduced across the globe to combat the issue, many in the industry have been slow to implement solutions that meet the new requirements.
Following the news that the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US has been pushed back to 2018, it is vital that all members of the pharmaceutical supply chain learn from the mistakes that have led to the delay. They must also have compliance with the European Falsified Medicines Directive (FMD) at the top of their agenda to ensure that they can continue to operate in key markets. Recent industry research suggests that many pharmaceutical manufacturers are not on track to meet the EU Falsified Medicines Directive (FMD).