From 2019, all licensed pharmaceutical products sold in Europe will need to be marked with a serial number under supply chain security measures set out in the EU Falsified Medicines Directive (FMD).
Similar – albeit subtly different – serialization requirements will come into force in the US next year under the US Drug Supply Chain Security Act (DSCSA), which is part of the Drug Quality and Security Act (DSQA) signed into law in 2013.
The new regulations are a challenge for drug companies that supply these markets. One approach is to invest in serialisation technology flexible enough to be tailored to each set of requirements and keep track of measures scheduled to be introduced over the next decade.
The other option – according to Recipharm - is to find a contract manufacturer capable of meeting serialization requirements in each market.
The Swedish CDMO has said it will invest €40m ($45m) in serialization technology over the next three years. It has also set up a steering committee to help clients plan and implement changes that comply with pending regulatory requirements.
The firm told us "The EUFMD is clear on its requirement on serialisation as such but the equipment to be used for making it happen is not regulated. There are a number of equipment suppliers that provide hard and software which can produce track and trace system including safety features meeting the requirement. Producers making the serialised packs are responsible to ensure/prove that products meet the EUFMD regulation."
Korea history
Recipharm has something of a track record in serialization. Last March, the contract manufacturing organisation (CMO) developed a data matrix code and serial number that was compliant with South Korean regulations on behalf of US drugmaker Abbott.
The firm has also helped clients meet serialization requirements already introduced in Turkey and China.
Recipharm's experience in serialization is not shared by some drug companies.
The firm told us: "Customers' preparation for serialisation vary a lot. Customers who have internal production to adopt to serialisation is very well prepared while other customers are not" adding that "so far we haven’t seen any panic among our customers."