The Falsified Medicines Directive – the overseas cousin of our Drug Supply Chain Security Act (DSCSA) that protects the European public from counterfeit, stolen, expired, and recalled drugs – became law this past January. It sets in motion a number of requirements for pharmaceutical manufacturers, distributors, and wholesalers doing business in the 28-nation E.U.
It’s an important step: Including the 28 E.U. member countries, there are now 40 countries in the world with active serialization regulations. These 40 countries make up 90 percent of the world’s population, which consumes – not surprisingly – 90 percent of the world’s pharmaceuticals. With the health and safety of so many people at stake, you’d expect there to be strong international standards that serve as a backbone for serialization regulations – but you’d be wrong. For any company doing global pharma business, there are a number of regulatory challenges to consider.
The Differences: U.S. DSCSA vs. E.U. Falsified Medicines Directive
There are other differences, too, such as the difficulty of getting global support from key vendors, and the need to run global serialization as a local project with local teams (or local/global hybrid teams). In short, global serialization deployment is a technically difficult and labor intensive undertaking.
The Big Similarity
Time crunch. Serialization implementation schedules are always longer than companies imagine. According to a SecurityIndustry.com article looking at the Delegate Act, “Estimates are that making the necessary changes to packaging lines and IT systems to incorporate serialization – and verify that the systems are working properly – can take as long as two years from start to finish.” While larger manufacturers have more resources and bigger budgets that help them overcome some of the time hurdles, smaller and mid-sized companies usually don’t.
Simplify Global Serialization, With LSPediA
We manage global serialization projects for companies of all sizes, simplifying every part of the process – gap analysis, strategy, IT infrastructure, vendor management, line execution, training, and other components. Regardless of which country you operate in, LSPediA ensures your organization can:
To learn more, contact me today. We’ll discuss how we can create a customized solution that fits your organization’s needs.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.