In their own way, the British have just disrupted! They wanted change and now it’s time for the the EU and the rest of the world to embrace it. As many may wonder, have they REALLY realized how much will have to change?
Just this morning, I was in discussion with one of the speakers for the 2016 DisruptiveRx Summit, an experienced global serialization expert. He mentioned to me, “I wonder if the pharma industry realizes the impact of Brexit on serialization regulation in Britain? Their current standards are that of the EU.” So, as of today, Britain is no longer with the EU, what are their regulations surrounding serialization? The answer right now is TBD!
Before the breaking news of Brexit, global serialization was already a challenge. Serialization is supposed to ensure the integrity of the drug supply chain so that manufacturers, packaging and logistics providers, patients and regulators know the drug supply chain is safe and secure.
If one considers the theory behind serialization at the unit level; the concept and outcome are rather simple: assign a unique code to each unit, track its journey through the supply chain and ensure it gets delivered to the patient without any issues along the way.
Of course in theory, everything looks perfect! Achieving true visibility through the entire drug chain continues to be a challenge. Part of the reasoning for this challenge is the madness around serialization standards.
Each pharmaceutical company come with a complex web of packaging, logistics, track and trace providers, and if you have CMOs integrated into your process, that adds another layer of difficulty. Each of these providers has their own technology, system and method of serialization making harmonization and collaboration within the organization a rather daunting task leading to inefficiency and doubt in the supply chain. Making it more complicated, if you are a multinational company, you need to take all these existing variables and multiply them by the number of international regulatory bodies resulting in an unsolved puzzle of multiple entities that all need to align together.
Now back to Brexit. Their new-found “freedom” means that their standards can no longer be part of the EU. So, what is the UK’s regulatory guidance on serialization? The answer is unknown. At what does that mean for Pharma? Another serialization standard that will require more investment to secure consultants and technology firms to ensure they are compliant with British standards.
Despite all this compliance, there is no guarantee that the drug supply chain is secure and safe! Welcome to the simplicity of serialization…
The 2016 DisruptiveRx Summit will discuss global trends and issues such as the impact of Brexit while presenting forward-looking technologies and ideas to help pharma executives better connect their business strategy with innovation through disruptive thinking. Executives in manufacturing, enterprise IT and supply chain management at bio/pharmaceutical companies are invited to join us on November 1-2, 2016 in Raleigh, NC. Together with industry innovators, experts, tech gurus, and regulators, we will explore explosive technologies and breakthrough ideas on innovations in supply chain management and advancements in manufacturing technology to create a more agile, efficient and secure drug supply chain. Learn more at www.DisruptiveRxSummit.com.
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