By 2020 most major markets will have pharmaceutical serialization regulations in place, however it is not a one size fits all scenario with requirements and timelines differing across countries. In the third part of our Serialization Series, Zenith Technologies’ serialization director, Carlos Machado and our senior R&D product manager Matteo Barbieri discuss the different approaches to serialization across geographies and the benefits of global collaboration that goes beyond compliance.
The U.S. and the EU are making strides in regulatory reform to combat the threat of counterfeit drugs and minimize criminal activity. Under the European Commission’s Falsified Medicines Directive (FMD), manufacturers who sell or dispense medication in the EU will need to comply with new track and trace regulations by February 2019 and this will involve item level serialization, compliance reporting and verification of medication at the point of dispensing. Obligatory safety features consisting of a 2D barcode unique identifier and tamper-resistant packaging will be required to ensure the authenticity of medicinal products.
Meanwhile, in the U.S. the phased introduction of the Drug Supply Chain Security Act (DSCSA) provides the foundation for a full traceability solution from manufacturer to distributor by 2023. The next milestone in the introduction of the legislation will require manufacturers to mark packages with a product identifier, serial number, lot number and expiration date by November 2017, allowing products to be traced throughout the distribution network.
As the world’s top producer of both legitimate and counterfeit drugs, China has already implemented a phased track and trace solution based on the state’s Essential Drug List (EDL). Using the Chinese government’s E-code system, all drugs are assigned a unique serial number and any movement throughout the supply chain needs to be reported back. For overseas companies operating in China, the regulatory system does present barriers. For example, remote monitoring and reporting is not possible meaning a local Chinese agent will need to be appointed to handle all activity.
Similarly, manufacturers wishing to operate in Brazil face equally stringent regulatory requirements with serialization required at both item and case level, in addition to government reporting. Packaging must be completely sealed with a security stamp that cannot be reused to prevent tampering. Every member of the supply chain must capture, track, record and transmit data to the National Agency for Sanitary Surveillance (ANVISA).
There is no doubt that the landscape is complex. Whether companies must implement a full track and trace system or authenticate drugs at the point of sale, the lack of an overarching global regulatory framework for compliance means the ability to work closely together to guarantee patient safety and increase efficiency is essential.
But if we take a step back from the finer details, the long-term investment in a serialization solution can bring wider business benefits. Companies will have to adapt to the new regulations if they wish to remain competitive and should take advantage of this thinking time to make long lasting improvements to business processes and standard operating procedures (SOPs). By planning ahead it is possible to maximize organizational efficiencies that in turn will guarantee business continuity once regulations do come into force. Implementing a standardized serialization solution across your business can generate time and cost savings, while documented evidence on the quality of manufacturing can also reduce the likelihood of quality control issues and recalls. This can have a positive influence on your brand reputation, protecting shareholder value and profitability.
No matter how big or small your company is, serialization is going to impact you in some shape or form. Navigating the regulatory landscape across countries is only the first step in becoming serialization ready. Next up in the Serialization Series, Carlos Machado and Matteo Barbieri outline how to plan for serialization, including the importance of defining your project and preparing for challenges once the process goes live.